Thursday, January 20, 2011

Endodiabology October 2010 Issue 3

ENDODIABOLOGY
Endodiabology.blogspot.com

NORTHEAST
NEWSLETTER
FOR SPRs AND BOSSES TRAPPED
IN THE NORTHERN DEANERY

OCTOBER 2010
Editors: Shaz Wahid (shahid.wahid@sthct.nhs.uk) and
Petros Perros (petros.perros@ncl.ac.uk) and Arut Vijayaraman (riarut@aol.com )
Associate Editor: Srikanth Mada

StR PLACEMENTS (NTN year of training from 1st October 2008)
• Newcastle- Atif Munir (2), Sajid Ethol Kalathil (2), Catherine Napier (2), Naveen Aggarwal (2), Hamza Ali Khan (2), Agnieska Sawiecicka (1), Vacant
• North Tyneside/Wansbeck- Alison Heggie (1), Vacant
• South Tyneside- Nimanthe De Alwis (2)
• Gateshead- Eeelin Lim (5)
• Sunderland- Jacog Buckovan (1), vacant
• North Tees/Hartlepool- Sudeep Manohar (4), vacant
• Middlesbrough- Arif Ullah (4)/Kathryn Stewart (3), Naveen Siddaramaiha (4), Vacant
• Bishop Auckland/Darlington/Durham- Sathia Rajhavan(1), Vacant
• NGH- Srikanth Mada(4),
• Research with numbers (supervisor)- Stuart Little (3-Dr Shaw), Asgar Madathil (4-Dr Weaver), Sarah Steven (3-Prof Taylor), Anna Mitchell (1-Prof Pearce), Earn Gan (1-Prof Pearce), Arif Ullah (4-Prof Bilous from 3/11)
• Maternity Leave Rohana Wright (3), Anjali SanthaKumar (3), Kathryn Stewart till 3/11 (3)

MEETINGS / LECTURES / ANNOUNCEMENTS
• 7 October 2010 British Thyroid Association annual meeting: Royal college of pathologists; London: Contact s.h.s.pearce@ncl.ac.uk
• 15th-17th October 2010 Autumn Endocrine Retreat. Contact conferences@endocrinology.org
• 18 October 2010 National training scheme for the use of radioiodine in benign thyroid disease : Birmingham, UK ; Contact helen.flood@uhb.nhs.uk
• 21st October 2010 North East Obesity Forum, 4-6pm, Obesity & Ethnicity, Durham University. Contact Catherine Stone Catherine.Stone@aso.org.uk
• 26- 30 October 2010 : American Thyroid Association meeting : Palmsprings, USA : Website: www.thyroid.org
• 8th-10th November 2010 Society for Endocrinology Clinical Update, venue TBC. Contact www.endocrinology.org
• 9th November 2010 RCP Updates in Medicine, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk.
• 17th November 2010 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk.
• 18th-19th November 2010 ABCD autumn meeting, London. Contact www.diabetologists.org.uk followed by SpRs meeting 19th-21st November 2010.
• 24th November 2010 Northern Endocrine Region Research and Audit Group annual meeting, Lumley Castle, Durham 2pm-8pm. Contact shahid.wahid@sthct.nhs.uk
• 25th November 2010 Northern England Diabetes & Obesity Collaborative Research Meeting, The Marriot Hotel, Leeds 0900-1630. contact jane.mann@manchester.ac.uk
• 25th & 26th November 2010 Middlesbrough Insulin infusion Pump Course, James Cook University Hospital. Contact nicky.skippon@stees.nhs.uk
• 19th January 2011 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk.
• 26th January 2011 Northern Endocrine & Diabetes Winter CME, Freeman Hospital. Contact Sarah Steven(sarah.steven@doctors.org.uk ) or Srikanth Mada (srikanth.mada@nhs.net )
• 1st March 2011 SfE National Clinical Cases Meeting, Royal Society of Medicine, London. Contact conferences@endocrinology.org NOTE submissions deadline is 25th October 2010.
• 16th March 2011 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk
• 30th March – 1st April 2011 DUK Annual Professional Conference, London, ExCel ICC. Contact www.diabetes.org.uk NOTE abstract submission deadline 31st October 2010.
• 11th-14th April 2011 SfE British Endocrine Societies annual conference, Birmingham ICC. Contact conferences@endocrinology.org NOTE abstract submissions deadline 15th November 2010.
• 13th April 2011 Northern Region Acute Medicine Study Day, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk
• 5th-6th May 2011 ABCD spring meeting, London. Contact www.diabetologists.org.uk
• 11th May 2011 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk
• 24th May 2011 Northern Endocrine & Diabetes Summer CME, JCUH, Middlesbrough. Contact Sarah Steven(sarah.steven@doctors.org.uk ) or Srikanth Mada (srikanth.mada@nhs.net )
• 4th-7th June 2011 ENDO 2011, Boston, USA. Contact endostaff@endo-societ.org or www.endo-society.org/scimeetings .
• 16th June 2011 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk
• 24th – 28th June 2011 American Diabetes Association 71st Annual Scientific Sessions, San Diego, USA. Contact meetings@diabetes.org .
• 13th July 2011 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk
• 14th September 2011 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk
• 12th October 2011 Northern Endocrine & Diabetes Autumn CME, Durham. Contact Sarah Steven(sarah.steven@doctors.org.uk ) or Srikanth Mada (srikanth.mada@nhs.net )
• 16th November 2011 ½ day SpR G(I)M teaching, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk
• 30th November 2011 RCP Updates in Medicine, Freeman Hospital. Contact Lorraine Waugh 0191 223 1247 Lorraine.waugh@tfh.nuth.northy.nhs.uk.

TRAINING ISSUES
DIABETES & ENDOCRINOLOGY PIMD WEBSITE Our specialty website is available on http://mypimd.ncl.ac.uk/PIMDDev . Click onto the specialty training tab then follow to Diabetes & Endocrinology. This site is essential reading, especially for ARCP preparation.
Registering with PMETB It is essential that all new SpRs/StRs (even LATs) register with the PMETB through the newly created Joint Royal Colleges of Physicians Training Board (formally the JCHMT) on www.jrcptb.org.uk. Not doing so means your training is not counted.
Log Book/Portfolio Documentation It is a trainee’s responsibility to make sure their portfolio/log book is prospectively completed and the necessary signatures obtained. Any experience that is not signed off by your educational supervisor at the time cannot be counted towards training. The e-portfolio for DM&ENDO is available now for StRs.
Assessment tools Please see www.jrcptb.org.uk; it is the trainee’s responsibility to give all the appropriate forms to their Educational or Clinical Supervisor. It is the trainee’s responsibility to make sure that the appropriate assessment summaries are available in their portfolio for ARCP purposes, e.g. MSF Summary Form.
Documenting CCU and ITU experience It is essential that trainees document their CCU and ITU experience. This is best done by keeping a summary log of the cases seen on CCU and ITU and linking it with reflection or assessment. This should then be signed off by your Educational Supervisor to be of any use at the Acute Medicine PYAs.
Audit Assessment tool This is now available in draft form on the JRCPTB website. Its use is highly recommended.
MRCP Diabetes & Endocrinology This exam has to be completed and passed by all trainees appointed after August 2007 before their PYA. We recommend sitting it ASAP and well before your PYA.
The Kelly-Young MRCP Diabetes & Endocrinology Prize This year sees the inaugural prize for SpRs passing the MRCP Diabetes & Endocrinology exam with the highest mark in the region. Richard Quinton secures the funding of £800 and it is named after 2 distinguished former Endocrinologists in the region, Bill Kelly and Eric Young. The prize will be presented at this year’s NERRAG meeting by both Bill and Eric to the 3 SpRs sharing the prize: Atif Munir, Nimanthe De Alwis and Sajid Ethol Kalathil.
INFORMATION for QA Could each individual trainer send the following to Simon Pearce: educational qualifications, any training positions held and any educational courses attended.
MORE INFORMATION for QA Could each unit’s Training Lead please send to Simon Pearce a completed training unit information report and an updated SpR/StR job description.
Trainers & Trainees meeting The next T&T is on 14th June 2011. Details to be confirmed nearer the time, but please note in your diary.
Another Trainee Rep on STC With Jeevan’s Consultant appointment a vacancy will exist from July 2010. Could interested SpRs please contact Nicky Leech.
TRAINERS EVENT 13th October 2010 This morning session is specifically for the faculty of trainers in Diabetes&Endocrinology in the Region. It promises to be an interesting morning with sessions on NHS Education England, Trainees in difficulty and on the job work based assessments.
ARCPs 2011 Mon 16th, Tues 17th, Weds 18th May 2011. SpRs keep these dates free and volunteers for the panel please contact Nicky Leech. Minimal requirements will be: thorough portfolio documentation, 4 Case based Discussions, Reflective accounts, Personal library evidence of teaching attendance and reflection, 4 new Mini-CEXs since last ARCP, MSF from current unit with at least 12 returns and 3 consultants, Updated PDP This should be drawn up and discussed with your supervisor within 4 weeks of starting your new post and Supervisors sign off and report.
NEDS CME Has undergone a revamp. See letter from Rohana Wright below.
Critical incident/complaint If you are involved in a critical incident or if reporting an incident concerning training issues please inform your supervisor and the TPD. Ensure they are reflected upon in your portfolio
Medicine ARCP Will remain separate next year. Date 19th May 2011. Continue to add evidence to the curriculum and demonstrate progression. Keep detailed anonomised logs and link them. Make the portfolio easy to navigate. You will need a MSF, Patient survey(if available), 6 ACATs, 6 CEX s, 4 CBDs, and be involved in a medical audit cycle.
Training Committee Chair- Simon Pearce, s.h.s.pearce@ncl.ac.uk; Regional Speciality Advisor- Shaz Wahid, shahid.wahid@sthct.nhs.uk; Programme Director- Nicky Leech nicola.leech@nuth.northy.nhs.uk; Consultant member (SAC rep)- Richard Quinton, Richard.Quinton@nuth.nhs.uk; Consultant member-Jean MacLeod, Jean.Macleod@nth.nhs.uk; Consultant member-Arutchelvam Vijayaraman Vijayaraman.Arutchelvam@stees.nhs.uk ; Consultant member-Simon Eaton, simon.eaton@northumbria-healthcare.nhs.uk; SpR representative-Recant Mada srikanth.mada@nhs.net ; SpR representative-

NEWS FROM THE NORTHEAST
• Congratulations to Shafie Kamruddin on his new appointments Consultant at Northallerton.
• Latika Sibal won the prize for best submitted oral presentation at the Heart UK meeting this summer. The work presented was part of the work in Newcastle for her PhD, awarded earlier this year. She continues in the locum consultant post at Addenbrooke's Hospital.
• Philip Home was invited by the American Diabetes Association to speak for the third time in four years at its Annual Congress in Orlando in June.
• Philip Home is now a member of the Steering Committee of the T-Emerge-8 CV outcomes study on taspoglutide, and the data safety boards of the Alecardio CV outcomes study on aleglitazar and the CANVAS study of canaglifloxicin, the latter for which he is Chair.
• For NICE Philip Home continues to chair the extended review of lapatinib, a novel breast cancer drug acting on the protein (tyrosine) kinase part of the growth factor receptor.
• Congratulations to Srikanth Made as a new Associate Editor for ENDODIABOLOGY.
• Congratulations to all 10 StRs in the region who sat the MRCP Endocrine exam and passed! 3 were 1st yr StRs. Well done to all.
• Sarah Steven and Srikanth Mada have joined Rohana Wright and Steve Ball on the NEDs CME committee.
• Srikanth Mada and Nimanthe De Alwis have taken over from Jeevan Mettayil in organising the SpR Management Forum.
• Srikanth Mada has joined the School of Medicine STC and Executive Committee as a trainee representative.
• Richard Quinton did an excellent job at the debate on testosterone in Type 2 Diabetes in the ABCD meeting. He was against the motion with Hugh Jones for the motion. Well done Richard.

LETTERS
The NEDS CME undergoes a revamp-Rohana Wright
This is just a reminder that the next CME day takes place on Tuesday 5th October at James Cook. This will follow the usual 9.30am-4.30pm structure as this date was booked prior to the decision to alter our format. And the dates for 2011 have now been confirmed:
Wednesday 26th January, Freeman Hospital; Tuesday 24th May, Durham; Wednesday 12th October, James Cook.

These days will all follow a new format, beginning at 1.30pm, finishing at 6.30pm, and will follow our curriculum based approach. There will also be non-clinical sessions incorporated into the programme. As you can see we are going to hold the May session in Durham, for a bit of a change of scenery, and we hope to use additional venues throughout the region in the coming years.

As I am now on maternity leave, any CME-related queries should be addressed to Sarah Steven (sarah.steven@doctors.org.uk ) or Srikanth Mada
(srikanth.mada@nhs.net ) who will be taking over my organisational duties while I am off.

DUK- Giggleswick Children’s summer camp-Srikanth Mada
I had a wonderful opportunity to volunteer as a clinical lead for DUK children’s summer camp held at Giggleswick school, north Yorkshire. It’s a week long camp consisting 60 children with type 1 diabetes between age groups 7 to 14 years. Each group consists of 10 children, one clinical lead, one dietician, two group leaders and a group supporter. Clinical leads take the handover of children from the parents and agree to achieve 3-4 objectives during their stay. The holiday is packed with high adrenaline activities such as caving, canoeing, kayaking, labyrinth, rock-climbing, high ropes, archery, abseiling,
and all day trip to Blackpool pleasure beech. Apart for all the fun it is an excellent opportunity to get a real time experience in understanding what it is living with diabetes and managing type 1 diabetes out side clinic setting. We get to teach them how to check BM’s, how to rotate sites, insulin titration, CHO counting and managing hypos. This camp gave me a real insight into living with diabetes, how disturbing and frightening a hypoglycaemic episode can be. An opportunity to understand managing diabetes in non clinic setting. One of the duty of group leads is to do midnight “hyporounds” as per rota to check kid’s at risk of nocturnal hypo following hectic day activity and manage them appropriate, which its self is a good learning experience. It is highly rewarding to see that kids injecting insulin on their own (who has never done before), successfully manage to rotate injection site, understand managing hypo and learn carbohydrate counting.
There were only 2 diabetologist’s (myself and the camp organiser) and rest 4 clinical lead slots were filled in by our specialist nurse colleagues- probably an opportunity that trainees need to grab in future. I strongly recommend all my colleagues SpR’s to consider attending one of these camps during their training, its great fun and excellent learning opportunity.

7-habits course at South Tyneside-Shaz Wahid.
New and old Consultants along with any StRs rotating to South Tyneside will be offered attendance at the in-house 7-habits course our Training & Development Dept. deliver 3 times a year. I am please to say Nimanthe has accepted the offer, just need to get Jon onto it before he retires! Here is the blurb:
“Stephen R. Covey is an internationally respected leadership authority. His book ‘The 7 Habits of Highly Effective People’ is an international best-seller and has been named as one of the 10 most influential management books ever. This flagship leadership programme has received very positive feedback from recent delegates and we would strongly encourage you to attend as part of your personal and professional development. The Signature Course has been modified to enable us to deliver this training in a 2-day workshop format – commencing at 8am and finishing around 5pm on both days. The venue for this event is to be confirmed but will be either Training & Development or the Ingham Wing Conference Room.

The aim of the workshop is to turn ineffectiveness into effectiveness with The 7 Habits which are briefly outlined below:
Habit 1: Be Proactive
Recognise how choices based on personal experience or beliefs can profoundly impact your effectiveness, both positively and negatively.
Habit 2: Begin with the End in Mind
Develop a clear definition of what is and is not important to you by creating your Personal Mission Statement.
Habit 3: Put First Things First
Increase the balance and fulfillment of your professional and personal life by investing a few minutes each day in the planning process.
Habit 4: Think Win-Win
Build a team that finds faster and better solutions through clear expectations, shared responsibilities, and an understanding of priorities.
Habit 5: Seek First to Understand Then to Be Understood
Develop the skills of effective communication that lead to greater influence and faster problem solving.
Habit 6: Synergize
Value and celebrate differences and understand how they contribute to more innovative and intelligent solutions.
Habit 7: Sharpen the Saw
Maintain and increase your newfound effectiveness by continually renewing yourself mentally and physically.”
Will be working on an 8th habit course soon!

RECENT PUBLICATIONS FROM THE NORTHEAST
1. Diabetes, falls and fractures. Mayne D, Stout NR, Aspray TJ. Age Ageing. 2010 Sep;39(5):522-5. Epub 2010 Jul 14.
2. Vitamin D and fractures: where are we now? Aspray TJ, Francis RM. Maturitas. 2010 Jul;66(3):221-2. Epub 2010 Apr 7.
3. Advani A, Johnson SJ, Nicol MR, Papacleovoulou G, Evans DB, Vaikkakara S, Mason JI, Quinton R. 2010 Adult-onset hypogonadotropic hypogonadism caused by aberrant expression of aromatase in an adrenocortical adenocarcinoma. Endocrine Journal. May 13. [Epub ahead of print].

4. Sykiotis GP, Plummer L, Hughes VA, Au M, Durrani S, Nayak-Young S, Quinton R, Hall JE, Gusella JF, Seminara SB, Crowley WF, jr, Pitteloud N. 2010 The oligogenic basis of idiopathic hypogonadotropic hypogonadism. Proceedings of the National Academy of Sciences of the United States of America. 107:15140-150144.

5. Gianetti E, Tusset C, Noel SD, Au MG, Dwyer AA, Hughes VA, Abreu AP, Carroll J, Trarbach E, Silveira LG, Costa EM, de Mendonça BB, de Castro M , Lofrano A, Hall JE, Bolu E, Özata M, Quinton R, Amory JK, Stewart SE, Arlt W, Cole TR, Crowley WF jr., Kaiser UB, Latronico AC, Seminara SB. 2010 TAC3/TACR3 mutations reveal preferential activation of gonadotropin-releasing hormone release by neurokinin B in neonatal life followed by reversal in adulthood. Journal of Clinical Endocrinology & Metabolism. 95: 2857-2867.

6. David Woods. Angiotensin-Converting Enzyme, Renin-Angiotenson System and Human Performance. Genetics and Sports. Medicine and Sport Science 2009, Vol 54, pp 72-87.

7. Boos CJ, Wheble GA, Campbell MJ, Tabner KC, Woods DR. Self-administration of exercise and dietary supplements in deployed British military personnel during Operation TELIC 13. J R Army Med Corps. 2010 Mar;156(1):32-6.

RECENT PUBLICATIONS IN DIABETES & ENDOCRINOLOGY THAT HIT THE NEWS OR THAT MAY HAVE A SIGNIFICANT IMPACT ON MANAGEMENT
Carcinoid Syndrome R Srirajaskanthan et al. BMJ 2010341:c3941. An excellent case reminding us how easy it can be to miss Carcinoid syndrome.
Opioid induced hypogonadism. RG Reddy et al. BMJ 2010;341:c4462. 2 case reports suggesting an association between opioids and hypogonadism. I certainly came across a case of this in a 23 yr-old woman when I was a SpR in PIU at the RVI (many moons ago!).
Primary ovarian insufficiency. M De Vos et al. Lancet 2010;376:911-921. An excellent review article well worth a read.
“Liberating the NHS”-another attempt to implement market forces in English health care. Nick Black. NEJM 2010;363:1103-1105. I have read plenty of articles on the white paper in the medical literature, but none as good as this. However, the best articles have been in the Health Service Journal that I read as part of my management role. I dare you to read it………………………………………………………….
Large prolactinoma. M Ahmed & O Al-Nozha. NEJM 2010;363:177. An excellent picture for teaching.
Management of people with diabetes wanting to fast during Ramadan. E Hui et al. BMJ 2010;340:c3053. A wonderful, practical review article that should be staple reading for trainees and an annual reminder for us senior folk.
Functional hypothalamic amenorrhoea. CM Gordon. NEJM 2010;363:365-371. A practical review article worth a read.
Diabetic Nephropathy. N Cheung et al. Lancet 2010;376:124-136. An excellent update well worth a read.
Calcium kidney stones. EM Worcester & FL Coe. NEJM 2010;363:954-963. Kidney stones are now on the new specialty curriculum, hence this article is very timely and good to boot!
Obesity therapy trials. 2 recent trilals detailing treatment with naltrexone&bupropion and Lorcaserin for weight management are worth a read with their accompanying editorials: FL Greenway et. Lancet 2010;376:595-605; SR Smith et al. NEJM 2010;363:245-256.
Lancet Diabetes Theme Issue. The 2010 volume 375 June 26-July2 edition of the Lancet is worth a read in its entirety. It includes new therapy options with dapaglifozin and a head to head comparison of glargine insulin and once-weekly exenatide.
Investigating secondary hyperhidrosis. AN Paisley & HM Buckler. BMJ 2010;341:c4475. An excellent article reviewing the steps in investigating this common referral to Endocrine clinic.
Effects of medical therapies on retinopathy progression in type 2 diabetes. The ACCORD study group. NEJM 2010;363:233-244. In the ACCORD randomised trial 10,251 participants with type 2 diabetes who were at high risk for cardiovascular disease to receive either intensive or standard treatment for glycaemia (target HbA1c , <6.0% or 7.0 to 7.9%, respectively) and also for dyslipidaemia (160 mg daily of fenofibrate plus simvastatin or placebo plus simvastatin) or for systolic BP control (target, <120 or <140 mm Hg) were enrolled. A subgroup of 2856 participants was evaluated for the effects of these interventions at 4 years on the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study Severity Scale or the development of diabetic retinopathy necessitating laser photocoagulation or vitrectomy. At 4 years, the rates of progression of diabetic retinopathy were 7.3% with intensive glycaemia treatment, versus 10.4% with standard therapy (adjusted odds ratio, 0.67; [95% CI], 0.51-0.87; P=0.003); 6.5% with fenofibrate for intensive dyslipidaemia therapy, versus 10.2% with placebo (adjusted odds ratio, 0.60 [0.42-0.87]; P=0.006); and 10.4% with intensive blood-pressure therapy, versus 8.8% with standard therapy (adjusted odds ratio, 1.23[0.84-1.79]; P=0.29). The authors conclude that intensive glyacemic control and intensive combination treatment of dyslipidaemia, but not intensive blood-pressure control, reduced the rate of progression of diabetic retinopathy. An excellent trial that adds weight to fenofibrate use in diabetic retinopathy in addition to statin therapy. Nice to see glycaemic control does not get a knocking and still a little baffled with the BP effect, however UKPDS did last longer.
Identification of late-onset hypogonadism in middle-aged and elderly men. Wu FC et al. NEJM 2010;363:123-135. The authors surveyed a random population sample of 3369 men aged 40 to 79 years at eight European centres, using questionnaires. The collected data included the subjects' general, sexual, physical, and psychological health. Levels of total testosterone were measured in morning blood samples by mass spectrometry, and free testosterone levels were calculated with the use of Vermeulen's formula. Data were randomly split into separate training and validation sets for confirmatory analyses. In the training set, symptoms of poor morning erection, low sexual desire, and erectile dysfunction, inability to perform vigorous activity, depression, and fatigue were significantly related to the testosterone level. Increased probabilities of the three sexual symptoms and limited physical vigour were discernible with decreased testosterone levels (ranges, 8.0 to 13.0 nmol/l for total testosterone and 160 to 280 pmol/l for free testosterone). However, only the three sexual symptoms had a syndromic association with decreased testosterone levels. An inverse relationship between an increasing number of sexual symptoms and a decreasing testosterone level was observed. These relationships were independently confirmed in the validation set, in which the strengths of the association between symptoms and low testosterone levels determined the minimum criteria necessary to identify late-onset hypogonadism. This trial suggests that late-onset hypogonadism can be defined by the presence of at least three sexual symptoms associated with a total testosterone level of less than 11 nmol/l and a free testosterone level of less than 220 pmol/l.
Adverse events associated with testosterone administration. Basaria S and Coviello AD, et al. NEJM 2010;363:109-122. In this trial Community-dwelling men, 65 years or older, with limitations in mobility and a total serum testosterone level of 3.5 to 12.1 nmol/l or a free serum testosterone level < 173 pmol/l were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidaemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population Limit extrapolation about the safety of testosterone therapy and certainly should not deter further trials. It is well worth reading the editorial by William Bremner (NEJM 2010;363:189-191) in relation to both of the above trials.
Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. Bergenstal RM, Tamborlane WV, et al. NEJM 2010;363:311-320. In this 1-year, multicentre, randomised, controlled trial, the efficacy of sensor-augmented pump therapy (pump therapy) with that of a regimen of multiple daily insulin injections (injection therapy) in 485 patients (329 adults and 156 children) with inadequately controlled type 1 diabetes was studied. Patients received recombinant insulin analogues and were supervised by expert clinical teams. At 1 year, the baseline mean HbA1c(8.3% in the two study groups) had decreased to 7.5% in the pump-therapy group compared with 8.1% in the injection-therapy group (P<0.001). The proportion of patients who reached an HbA1c <7% was greater in the pump-therapy group than in the injection-therapy group. The rate of severe hypoglycaemia in the pump-therapy group (13.31 cases per 100 person-years) did not differ significantly from that in the injection-therapy group (13.48 per 100 person-years, P=0.58). There was no significant weight gain in either group. This trial confirms the efficacy of the newer insulin pump technology in both adults and children with inadequately controlled type 1 diabetes.
Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial. Bergenstal RM, Wysham C et al. Lancet 2010;376:431-439. In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had a mean HbA1c of 8.5%(SD 1.1), fasting plasma glucose of 9.1 mmol/L (2.6), and weight of 88.0 kg (20.1), were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily (170-pts); 100 mg oral sitagliptin once daily plus injected placebo once weekly (172-pts); or 45 mg oral pioglitazone once daily plus injected placebo once weekly (172-pts). Primary endpoint was change in HbA1c between baseline and week 26. Analysis was by intention to treat, for all patients who received at least one dose of study drug. 491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone). Treatment with exenatide reduced HbA1c(least square mean -1.5%, 95% CI -1.7 to -1.4) significantly more than did sitagliptin (-0.9%, -1.1 to -0.7) or pioglitazone (-1.2%, -1.4 to -1.0). Treatment differences were -0.6% (95% CI -0.9 to -0.4, p<0.0001) for exenatide versus sitagliptin, and -0.3% (-0.6 to -0.1, p=0.0165) for exenatide versus pioglitazone. Weight loss with exenatide (-2.3 kg, 95% CI-2.9 to -1.7) was significantly greater than with sitagliptin (difference -1.5 kg, 95% CI -2.4 to -0.7, p=0.0002) or pioglitazone (difference -5.1 kg, -5.9 to -4.3, p<0.0001). No episodes of major hypoglycaemia occurred. The most frequent adverse events with exenatide and sitagliptin were nausea (n=38, 24%, and n=16, 10%, respectively) and diarrhoea (n=29, 18%, and n=16, 10%, respectively); upper-respiratory-tract infection (n=17, 10%) and peripheral oedema (n=13, 8%) were the most frequent events with pioglitazone. This trial confirms what we could have all predicted, that exenatide once weekly is more effective with less weight gain when added in second line compared to sitagliptin and pioglitazone. Personally, therapies for Type 2 diabetes have promulgumated and individualizing treatment is the correct thing to do. However, the basic tenants of lifestyle advice, metformin therapy and structured education remain the bedrock of all therapies.


NEXT NEWSLETTER Due out beginning of February 2011 so keep the gossip coming.

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