The concept of ‘remission’ of type 2 diabetes was recently defined by professional societies and discussed as a worthwhile treatment goal, but there is still no consensus on the best way to achieve it.
At the recent 2022 meeting of the International Diabetes Federation (IDF), the topic was discussed during a “hot topics” discussion in which one expert discussed how lifestyle changes can best achieve this goal, while another argued that bariatric surgery is a better option.
There are different definitions of “remission” for type 2 diabetes. One commonly used, from the American Diabetes Association, defines it as maintaining A1c levels <6.5% for at least 3 months without the use of medications to lower glucose.
Lifestyle: effective if done intensively and safer than surgery
Paramesh Shamanna, MD, medical director of Twin Health, Bangalore, India, told conference attendees that the type of lifestyle intervention employed is key.
Shamanna began by acknowledging that randomized controlled trials generally favor bariatric surgery for diabetes remission over non-surgical therapy for patients with type 2 diabetes and obesity, as shown in a recent meta-analysis.
However, he noted that in many of the trials, the non-surgical treatments included for comparison were based on those from the Look AHEAD or Why WAIT studies.
However, an overview review published in 2022 in Diabetologia showed that more than half of the participants were able to achieve and maintain diabetes remission within 1 year using very low-calorie meal replacements (about 800 calories). One study in particular, DIADEM-1, which was published in 2020, showed a “remarkable” diabetes remission rate of 61% after an average weight loss of 12 kg (26.4 lbs.), Shamanna said.
And the DiRECT trial, which used an 800-calorie liquid diet followed by slow reintroduction of food, found a 46% diabetes remission rate with an average weight loss of 10 kg (22 lbs). Among those who lost 10 kg or more in weight, 73% experienced a remission at 12 months.
“This is equal to, or even better than, any study of bariatric surgery,” he commented.
In contrast, in the Look AHEAD and Why WAIT trials, remission rates were only 11.5% and 3.2%, respectively.
“Those are not a really good comparison. Most of the trials used as comparisons with bariatric surgery have very low remission rates, when in reality we should be using the DIDEM-1 or DiRECT program,” he said.
Using Look AHEAD or Why WAIT “is like comparing a heavyweight boxing champion to a strawweight guy. He was born to fail,” Shamanna quipped.
In addition, Shamanna pointed out that bariatric surgery also involves modifying the diet. People who undergo the procedures are usually required to follow a low-calorie diet in the lead up to surgery to reduce the volume of the liver. Subsequently, they must follow a liquid diet, then a diet consisting of pureed and soft foods for up to a month, and then a diet for life.
At least one study has provided evidence that diet, rather than surgery, may be responsible for the improvement in blood glucose in the immediate postoperative period. “We need to take a closer look at whether caloric restriction plays a larger role in bariatric surgery outcomes,” Shammana said.
He summarized the list of adverse effects associated with bariatric surgery, including a mortality rate of 0.1% to 1.1%, major complications in 2% to 6% of patients, and somewhat higher rates of malabsorption, anemia, dumping syndrome, hypoglycemia and psychiatric disorders. There is also a relatively high relapse rate (33% at 5 years with Roux-en-Y gastric bypass and 42% with sleeve gastrectomy) and reduced cardiorespiratory fitness.
Also, he noted, no reduction in health care costs was seen 6 years after surgery in one study, whereas in the DiRECT trial, there was a clear reduction in cost.
“We need studies that compare the efficacy and safety of these procedures with that of a truly intensive lifestyle intervention like the DiRECT trial, not just standard practice, and we need a true cost-benefit analysis,” he concluded.
Ultimately though, “millions of people ask for diabetes remission and lifestyle is the only scalable solution.”
Most data from randomized and observational clinical trials favor surgery
Arguing the alternative case ― that surgery is the best option to achieve remission ― was Brij Mohan Makkar, MBBS, MD, senior diabetes and bariatric physician and director of Dr. Makkar’s Center for Diabetes and Obesity, New Delhi, India.
Makkar began by noting that the concept of remission of type 2 diabetes with bariatric surgery dates back several decades. In a 2015 article in which researchers reviewed three meta-analyses, remission rates for type 2 diabetes among patients with a body mass index <35 kg/m2 ranged from 55% (29 studies) to 85%. % (16 studies) with follow-up. ups between 6 months and 18 years, using different bariatric procedures. All but one of these studies showed that bariatric surgery was statistically superior to conventional therapy, which in some studies included intensive lifestyle intervention.
And in five large randomized controlled clinical trials conducted between 2006 and 2013 with follow-up of 1 or 2 years, the remission rate for type 2 diabetes ranged from 39.4% to 93%, compared with 0% and 46.7% with conventional treatment.
A meta-analysis published in 2022 included 316 patients with type 2 diabetes who were enrolled in four trials comparing metabolic surgery with medical/lifestyle treatment. The proportions with A1c <6.5% without glucose-lowering treatment at 3 years were 37.5% with surgery versus only 2.6% with medical/lifestyle treatment (p < 0.001).
Makkar also mentioned the low long-term remission rate seen with Look AHEAD. As for DiRECT, she noted that type 2 remission rates dropped overall from 45.6% at 1 year to 35.6% at 2 years. Of the 36 patients who lost at least 15 kg (33 lb), 31 (86%) achieved remission at one year. However, at 2 years, only 14 of 20 (70%) maintained that weight loss.
Few, if any, studies of lifestyle intervention have lasted more than two years, Makkar noted. “We all know that lifestyle interventions are not easy to do,” he added.
He concluded: “Bariatric surgery showed us that diabetes remission can happen. There are 30 years of data supporting bariatric surgery and diabetes remission. We have observational studies, randomized controlled trials, and meta-analyses. What do we have for intervention? on lifestyle? DiRECT trial only, with 2-year follow-up. What’s next? We don’t know.”
Shamanna is an employee of Twin Health. Makkar has disclosed no relevant financial relationships.
Diabetes Federation (FID) Meeting 2022. Presented on December 7, 2022.
Miriam E. Tucker is a freelance journalist living in the Washington DC area. She is a regular contributor to Medscape and her other work appears in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.
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