Friday, April 4, 2014

Will Vitamin D Help You Lose Weight?

Vitamin D

Vitamin D

As a regular reader, you may well be aware of the discussions regarding a potential role of calcium and vitamin D in promoting weight loss.

Now, this issue was examined by Mason and colleagues in a 12 month randomised controlled trial, published in the American Journal of Clinical Nutrition.

The study involved 218 overweight/obese women (50-75 y of age) with moderate vitamin D deficiency (serum 25-hydroxyvitamin D [25(OH)D] ≥10 ng/mL but

The weight-loss intervention included a reduced-calorie diet (10% weight loss goal) and 225 min/wk of moderate-to-vigorous aerobic activity.

A total of 86% of participants completed the 12-mo measurements losing on average about 7 Kg, with no significant differences between the two groups.

There were also no significant differences in the reduction in BMI, waist circumference, percentage body fat, trunk fat, insulin or CRP levels.

At best, there was a slight trend towards greater benefits in women, who became replete with vitamin D supplementation compared to those who did not.

Thus, in summary, simply adding vitamin D to a weight loss regimen does little (if anything) to aid weight loss.

This is not to say that vitamin D supplementation in people with vitamin D deficiency may not be a good thing – it just does not appear to have much effect on body weight.

@DrSharma
Halifax, NS

ResearchBlogging.orgMason C, Xiao L, Imayama I, Duggan C, Wang CY, Korde L, & McTiernan A (2014). Vitamin D3 supplementation during weight loss: a double-blind randomized controlled trial. The American journal of clinical nutrition PMID: 24622804

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Thursday, April 3, 2014

Why Coverage Of Anti-Obesity Medications For Federal Employees Is Only Fair

OPM-logo

One of the rather explicit biases that has hindered greater investment into finding more effective obesity medications, has been the unwillingness of many health care plans to cover the cost of such medications for their members.

Indeed, many private and public health plans around the world explicitly exclude obesity medications (and other obesity treatments) from coverage.

This is clearly a double standard, given that the very same plans have no problem covering medications for other “lifestyle” diseases such as type 2 diabetes, hypertension, or high-cholesterol.

Now, in a rather dramatic move last month, the US Office of Personnel Management (OPM), responsible for health insurance coverage for  over 2.7 million Federal Employees, ruled in support of health coverage for FDA-approved weight-loss treatments stating that obesity exclusions are no longer permissible in health plans for federal employees.

This move should set an important precedent for other health plans to follow.

In the March 20th letter to all FEHB carriers, John O’Brien, the Director of Healthcare and Insurance at OPM, agrees that while

“diet and exercise are the preferred methods for losing weight, …drug therapy can assist [those] who do not achieve weight loss through diet and exercise alone.”

In the letter, O’Brien provides further clarification:

“It has come to our attention that many FEHB carriers exclude coverage of weight-loss medications. Accordingly, we want to clarify that excluding weight loss drugs from FEHB coverage on the basis that obesity is a “lifestyle” condition and not a medical one or that obesity treatment is “cosmetic”- is not permissible. In addition, there is no prohibition for carriers to extend coverage to this class of prescription drugs, provided that appropriate safeguards are implemented concurrently to ensure safe and effective use.”

This ruling should end the long-standing practice of discrimination against people with obesity who require and are willing to take medications for their condition.

Obviously, medications for obesity need to always be used as an “adjunct” to diet and exercise, in the same manner that medications for diabetes, hypertension or high-cholesterol should always be used as an adjunct to diet and exercise.

It goes without stating that prescription medications for obesity, diabetes, hypertension or high-cholesterol should only be made available to those who fail to control their weight, blood sugar, blood pressure, or cholesterol levels with diet and exercise alone. (there is no “special case” for the role of diet and exercise in obesity management that does not also apply to these other conditions).

And of course, as for any prescription drug, means and measures must be in place to avoid misuse and monitor safety of such treatments.

That said, recognizing that prescription obesity drugs, deemed both effective and safe by the FDA should be made available to patients in the same manner as drugs for other chronic conditions, is only fair to patients and represents a major step towards decreasing bias and discrimination against those suffering the health consequences of excess weight.

@DrSharma
Edmonton, AB

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Wednesday, April 2, 2014

Trotting Out STAMPEDE

sharma-obesity-blood-sugar-testing2In the obesity world, this week’s big news is the publication of the three year results of the STAMPEDE trial in the New England Journal of Medicine.

As a regular reader, you may recall my previous post on this randomised controlled trial of bariatric surgery for the treatment of type 2 diabetes.

STAMPEDE involved the randomisation of 150 obese patients with uncontrolled type 2 diabetes to either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy.

Rather than weight loss, the primary end point of STAMPEDE was a glycated hemoglobin (HbA1C) level of 6.0% or less (from a mean baseline of 9.3%).

For the 91% of the patients who completed 36 months of follow-up at three years, 5% of the patients in the medical-therapy group achieved an HbA1c of 6.0% compared to 38% of those in the gastric-bypass group and 24% of those in the sleeve-gastrectomy group.

In addition, surgically treated subjects overall had far lesser need for glucose-lowering medications, including insulin than those receiving medical treatment.

Weight was reduced by 20-25% in the surgical groups compared to a 4% weight loss in the medical arm of the study.

Quality-of-life was also significantly better in the two surgical groups than in the medical-therapy group.

There were no major late surgical complications.

By any reasonable standard, there cannot be any remaining doubt in anyone’s mind that surgical treatment for type 2 diabetes is vastly superior to anything that medical treatment has to offer.

Diabetologists and, in fact, all physicians, diabetes educators, dietitians and other health professionals, who fail to inform and counsel their type 2 patients with regard to surgical treatment options for their condition, risk being accused of malpractice.

Whether patients want surgery for diabetes or not is ultimately their choice – being informed of the potential benefits of surgery should not be a matter of choice – it should be good clinical practice.

@DrSharma
Edmonton, AB

Disclaimer: I am NOT a surgeon!

ResearchBlogging.orgSchauer PR, Bhatt DL, Kirwan JP, Wolski K, Brethauer SA, Navaneethan SD, Aminian A, Pothier CE, Kim ES, Nissen SE, Kashyap SR, & the STAMPEDE Investigators (2014). Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes. The New England journal of medicine PMID: 24679060

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Tuesday, March 25, 2014

Challenges in Pediatric Obesity Management

sharma-obesity-kids-scale2If treating obesity in adults is challenging, managing obesity in kids is even more daunting.

Now, a seminal paper by Jill Avis and colleagues (representing a virtual who-is-who of pediatric obesity management in Canada), published in Expert Reviews in Diabetes and Metabolism, with the fitting title, “It’s like rocket science…only more complex“, explores the many challenges in pediatric obesity management in Canada.

The thoughts and analyses presented in this narrative review are largely based on the responses to a national survey of folks providing pediatric “weight-management” services across Canada. Responses were sought to a range of questions, including:

In regards to managing pediatric obesity in Canada, what lessons have you learned related to: Caring for children?; Collaborating with clinicians and/or researchers?; and Working within the health care system? In addition, what do you consider to be important future directions for clinical care and research in Canada?

Apart from noting the importance and challenges of adopting a family centred approach, the paper highlights the importance of factors that go well beyond “eat-less-move-more” platitudes.

Thus, the authors note that,

“Internalizing (e.g., anxiety, depression) and externalizing (e.g., hyperactivity, aggression) disorders are common in children and adolescents with obesity, which can make management strategies more difficult to implement…..these realities highlight the need for mental health professionals to assume active roles in pediatric obesity management to explore, identify and manage families’ unique mental health concerns.”

With regard to the importance of weight bias, the authors state,

“Many parents in our care have experienced shame and blame from other family members, friends, coworkers and health professionals regarding the weight status of their children….The underlying assumption in this instance is that individuals with obesity just need to eat less and move more….a sentiment that demonstrates a lack of understanding and empathy.”

Thus,

” There is a clear need to shift from a singular focus on physical weight status to define the health of individuals with obesity to a nonjudgmental and unbiased appreciation of the complex causes and consequences
of obesity.”

Despite all efforts, the authors describe the outcomes of childhood obesity interventions as “modest”.

This has prompted a number of collaborative research initiatives including the Canadian Pediatric Weight Management Registry (CANPWR), the Should I Stay or Should I Go study and (in partnership with the Canadian Obesity Network) the development of a national network called Treatment and Research of Obesity in Pediatrics in Canada (TROPIC), whose purpose is to promote knowledge translation and dissemination of issues related to pediatric obesity management in Canada.

All of these activities demonstrate a high degree of collaboration and coordination among the pediatric obesity management community in Canada.

The paper also addresses the challenges of providing childhood obesity management services within the health care systems (which vary across provinces).

“…there is substantial heterogeneity across the multidisciplinary clinics we lead and work within; some are well-resourced (i.e., physical space, clinical, and administrative personnel), while others struggle with limited budgets to provide comprehensive and long-term care for families.”

“…relatively small numbers of patients (compared with other outpatient pediatric clinics [e.g.,general pediatrics]) and a lack of substantial weight loss for most children and adolescents with obesity…necessitate education, contextualization and justification to colleagues and administrators within the health care system so that obesity is viewed not as a simple problem that requires a quick fix in order to achieve weight loss, but as a chronic disease that requires ongoing support and management.”

Important work to aid clinicians include the adaptation of the Edmonton Obesity Staging System for pediatric populations (EOSS-P), the family centred adaptation of the 5As of Obesity Management for managing pediatric obesity in primary care, and CONversation cards, a tool to facilitate discussions between clinicians, parents and kids on issues related to healthy lifestyle changes.

Finally, the paper discusses the many barriers to accessing timely obesity management including costs (travel, parking, time off work), geography (distances) and wait times.

Clearly, despite all progress, significant challenges remain to be addressed – “it’s like rocket science…only more complex.”

@DrSharma
Edmonton, AB

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Wednesday, March 19, 2014

Can Testosterone Lead to Weight Loss in Hypogonadal Men?

sharma-obesity-impotenceLoss of male gonadal function has been associated with weight gain (particularly visceral adiposity) as well as metabolic disturbances including dyslipidemia and insulin resistance.

However, wether or not hormonal substitution with testosterone (T) ameliorates these metabolic abnormalities or even leads to weight loss remains controversial.

Now a 6-year observational study by Ahmad Haider and colleagues from Germany, published in the International Journal of Endocrinology, strongly suggests that this may well be the case.

The authors analysed data from two prospective longitudinal studies that included 156 obese hypogonadal men, aged between 41 and 73 years (mean 61.17 ± 6.18) with previously diagnosed type 2 diabetes, who were seeking urological consultation for various conditions such as erectile dysfunction, decreased libido, questions about their T status, or a variety of urological complaints.

All subjects  had subnormal plasma total T levels and at least mild symptoms of hypogonadism assessed by the Aging Males’ Symptoms scale (AMS).

Treatment was started with parenteral T undecanoate 1000 mg (Nebido, Bayer Pharma, Berlin, Germany), administered at baseline and 6 weeks and thereafter every 12 weeks for up to 72 months. Subjects were also given general advice on healthy eating and physical activity.

This treatment resulted in an increase in total T levels from 8.9 ± 1.99 nmol/L to above 16 nmol/L within the first year of therapy, and remained at this physiological level throughout the course of treatment.

This change in T levels was associated with a progressive 12 cm decrease in waist circumference and weight loss of about 17.5 Kg (15% of initial weight) with BMI dropping from 36.5 to 31.2 at year 6.

Concomitantly, fasting glucose declined from 7.06 to 5.59 mmol/L and HbA1c decreased from 8.08 to 6.14%.

There were also favourable changes in systolic and diastolic blood pressure, lipid profiles including triglycerides and total cholesterol:HDL ratio, as well as CRP and liver enzymes.

While general caution is in order given that there was no control group, these finding certainly strongly suggest a possible role for T-replacement therapy in hypogonadal males presenting with symptoms of hypogonadism and weight gain.

Clearly, the 15% weight loss is impressive and well-exceeds what is generally seen with pharmacological obesity treatments.

If nothing else, these observations should prompt the conduct of a well-designed randomised controlled trial to confirm the effect and safety of T replacement therapy for obesity in hypogonadal men.

@DrSharma
Edmonton, AB

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In The News

Diabetics in most need of bariatric surgery, university study finds

Oct. 18, 2013 – Ottawa Citizen: "Encouraging more men to consider bariatric surgery is also important, since it's the best treatment and can stop diabetic patients from needing insulin, said Dr. Arya Sharma, chair in obesity research and management at the University of Alberta." Read article

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