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CROSSROADS trial

Surgery beats ILMI at reversing T2DM

CROSSROADS trial shows surgery beats intensive lifestyle/medication intervention at reversing type 2 diabetes in patients with only mild-to-moderate obesity

The outcomes from the CROSSROADS trial (Calorie Reduction Or Surgery: Seeking to Reduce Obesity And Diabetes Study) shows that bariatric surgery is much more effective than an intensive lifestyle/medication intervention ((ILMI) at reversing type 2 diabetes in patients with only mild-to-moderate obesity. The paper, ‘Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial’, published in Diabetologia (the journal of the European Association for the Study of Diabetes [EASD]) underlines that it may no longer be appropriate to consider someone for bariatric surgery based primarily on just their body mass index, but also on whether they have diabetes.

The study authors, led by Dr David E Cummings, Department of Medicine, University of Washington, Seattle, WA, USA, compared roux-en-Y gastric bypass (RYGB) to ILMI for type 2 diabetes, including among only mildly obese patients with a BMI<35.

"Compared with the most rigorous intensive lifestyle and medical intervention yet tested against surgery in a randomised trial, RYGB yielded greater type 2 diabetes remission in mild-to-moderately obese patients recruited from a well-informed, population-based sample," the authors wrote.

By use of a shared decision-making recruitment strategy targeting the entire at-risk population within an integrated community healthcare system, the researchers screened 1,808 adults meeting inclusion criteria (age 25-64, with type 2 diabetes and a BMI30-45). Due to a wide range of factors including each patient's pre-held beliefs about what might or might not be successful for them, it was very difficult to get patients to agree to be randomised to surgery or non-surgery.

As a result, only 43 were randomly allocated in a 1:1 ratio to RYGB or ILMI. The lifestyle intervention involved 45 minutes or more of aerobic exercise 5 days or more per week, a dietician-directed weight- and glucose-lowering diet, and optimal diabetes medical treatment for one year. Although treatment allocation could not be blinded, outcomes were determined by a blinded adjudicator. The primary outcome was diabetes remission at one year (HbA1c <6.0% and not taking any diabetes medicines).

A total of 23 volunteers were assigned to RYGB and 20 to ILMI. Of these, 11 withdrew before receiving any intervention, leaving 15 in the RYGB group and 17 in the IMLI group to be analysed for the whole year. The groups were equivalent regarding all baseline characteristics, except that the RYGB cohort had by chance a longer diabetes duration (11.4 versus 6.8 years).

Weight loss at one year was 25.8% for RYGB versus 6.4% ILMI, respectively. The ILMI exercise programme yielded a 22% increase in exercise capacity, whereas after RYGB exercise capacity was unchanged. Diabetes remission at one year was 60% with RYGB versus 6% with ILMI. The HbA1c decline over one year was only modestly more after RYGB than ILMI: from 7.7% to 6.4% vs 7.3% to 6.9%, respectively; however, this drop occurred with significantly fewer or no diabetes medications after RYGB. No life-threatening complications occurred in either group.

"These results apply to patients with a BMI of 30-35 kg/m2, as well as to more obese patients, and our study and others show that neither baseline BMI nor the amount of weight lost dependably predicts diabetes remission after RYGB, which appears to ameliorate diabetes through mechanisms beyond just weight reduction,” they added. “These findings call into serious question the longstanding practice of using strict BMI cut-offs as the primary criteria for selection for bariatric surgery among patients with type 2 diabetes."

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