Bariatric Surgery Beats Lifestyle Changes for Type 2 Diabetes

February 28, 2024 – When Kristen Hugus was offered the chance to participate in a medical study that randomly assigned people with type 2 diabetes to bariatric surgery or intensive lifestyle and medication coaching , she thought of her 4-year-old daughter. .

“I was so tired all the time, and the summer before all this happened to me, I remember I was laying on the couch while it was a beautiful day outside and my daughter really wanted to do things, and I just didn’t have the energy,” she recalls. “Even though it was a scary prospect to have major surgery, the chance to be healthy, for me, was something I just couldn’t pass up, because I wanted to be able to be a good example for my daughter. »

Hugus was randomly assigned to the study to undergo gastric bypass surgery, sometimes called bariatric surgery. That was in 2010, and shortly after, she no longer needed to use insulin to manage her blood sugar, and her blood sugar level on the commonly used A1c test fell into a much safer range. Over time, the 5-foot-2 registered nurse saw her weight decrease by 33 percent, from 188 pounds to about 125 pounds.

Now 50 years old and living in a suburb outside of Pittsburgh, Hugus has maintained these health benefits for more than 10 years. Its results represent, to a large extent, the overall conclusions of the study, which were published Tuesday at The Journal of the American Medical Association.

The researchers reported that the 166 patients who underwent bariatric surgery were significantly more likely to have improved glycemic control, diabetes remission, reduced cholesterol levels, and maintained much of their weight loss for a dozen years, compared to the 96 people treated with medical management and lifestyle. changes based on approaches known as Look AHEAD and the Diabetes Prevention Program. This is the longest follow-up comparison to date of people with type 2 diabetes who were randomized to treatment using bariatric surgery versus medical management/lifestyle . All people in the study initially had type 2 diabetes and were either overweight or obese.

The study answers a long-standing question about whether surgical results can last, similar to current questions about blockbuster weight loss drugs and whether they provide lasting results.

People whose treatment involved lifestyle interventions received intensive nutritional counseling as well as behavioral counseling for at least one year. People in the surgical group underwent one of three types of bariatric surgery: gastric bypass, gastric sleeve, or banding, the latter of which is no longer commonly used. Bariatric surgeries alter the stomach or small intestine, affecting the number of calories a person can consume or absorb.

After 7 years, 18% of operated patients had achieved remission of diabetes, compared to 6% of those in the medical/lifestyle group. But after 12 years, no one in the lifestyle group was still in remission, while 13% in the surgery group remained so. But the remission rate for the surgical group was much higher (nearly 51%) after the first year, and the medical/lifestyle group, in contrast, improved its remission rate by less than 1% after the first year. year.

This suggests “that bariatric surgery is an effective intervention for better management of diabetes, but that its effects are not as long-lasting as hoped,” Neda Rasouli, MD, director of the Diabetes Clinical Trials Program and endocrinology at the University of Colorado School of Medicine, said in an email. She did not participate in the study.

People in the lifestyle group were also treated with medication. Before the operation, almost everyone in the operated group was also taking medication for diabetes, but a year after the operation, only 38% were still taking medication, although this increased to 61% after 7 years.

“So it’s really important to highlight that. You can’t say that surgery permanently takes everyone off of all medications. “Surgery results in improved glycemic control and improved diabetes remission and this improvement, other studies have shown quite clearly, has somewhat of an inherited effect,” said the study’s lead author. , Anita P. Courcoulas, MD, professor of surgery. at the University of Pittsburgh School of Medicine. “So even if you benefit from a short period of diabetes remission and better glycemic control, you probably improve your chances of not developing microvascular and macrovascular complications of diabetes, such as heart attack, stroke , ocular, plantar and renal complications.”

But Rasouli noted that the study did not find a reduced risk of heart and vascular problems among people in the surgical group, although that may be due to some aspects of the study design.

After 12 years, researchers reported that the average sustained weight loss was 19% for surgery patients and 11% for medical/lifestyle patients.

Importantly, researchers were able to look at a subgroup of people with a lower body mass index or BMI (up to 30) and found that this lower BMI group had better outcomes with bariatric surgery, compared to the medical/lifestyle approach. . (BMI is a measure of a person’s body fat based on their height and weight.)

Revolutionary new treatments using a class of drugs called GLP-1 agonists were not a major part of the study because investigations began between 2007 and 2013, before these new drugs, like Ozempic and Mounjaro, became popular.

But because the follow-up period in this study was so long, many patients in both treatment groups eventually started taking GLP-1 agonist drugs.

The study is known as the Alliance of Randomized Trials of Medicine vs. Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) and was funded by the National Institutes of Health. It started with four separate but similar studies that were then merged for analysis. The four research centers participating in the project were the University of Pittsburgh, the Cleveland Clinic, the Joslin Diabetes Center and Brigham and Women’s Hospital, as well as the University of Washington and Kaiser Permanente Washington.

Because the study began as four separate studies, there are some limitations to the results, Rasouli noted, such as treatment approaches that are not 100% identical and varying follow-up periods. Fewer people in the medical/lifestyle group participated in long-term follow-up, compared to those in the surgery group.

“Usually, participants who did not respond well to the intervention are more likely not to participate in long-term follow-up,” she said.

Although people in the surgical group tended to have better health outcomes, they were more likely than people in the medical/lifestyle group to have adverse events after surgery, such as anemia, fractures and intestinal problems. The problems are not classified as serious by the medical community. But, Courcoulas noted, “they are certainly important to a patient because they can cause symptoms in the patient.”

Tracking these side effects allows providers to notify patients in advance about what might happen after surgery, said Courcoulas, who is also chief of minimally invasive bariatric and general surgery at the Medical Center. University of Pittsburgh.

Hugus said she is well aware of what to expect and how to reduce the risk of having these problems after her gastric bypass. She completely changed the way she ate.

“A lot of things have changed for me psychologically and physically. I physically have a barrier: if I eat too much, I don’t feel good. But psychologically, it made me really aware of the portions and how much we all actually eat, and it gave me perspective on how to eat better,” she said.

“I knew, for example, that if I ate too much or consumed too many carbs too quickly, I could get what’s called dumping syndrome, which is basically really bad diarrhea really quickly, and you don’t know it all. “It just doesn’t happen,” Hugus explained. “Or, if I took too much at once, it might make me vomit. So that was a challenge at first, because it was just getting used to it. to your limits and to listen to your body.

Overall, about 1 in 4 surgery patients reported some type of gastrointestinal problem, compared to 16% of people in the medical/lifestyle group.

In the medical/lifestyle group, 25% of people underwent surgery during the follow-up period, the researchers reported, but additional analysis indicated that subsequent surgery was unlikely to have occurred. Dramatically affected study results regarding change in glycemic control based on participants’ A1c levels.

“The range of treatments available to treat obesity in people with type 2 diabetes has evolved over the years, just as it is evolving now with new medications,” Courcoulas said. “And I think during the study period, which was many years… people who couldn’t control their diabetes said, ‘I’m going to move on to the next level of treatment.’ »

She said the same concept of adding or testing new treatments applies to the introduction of GLP-1 agonist drugs, whose ranks also include semaglutide and tirzepatide – known under the brand names Ozempic and Mounjaro . They were approved by the FDA for the treatment of diabetes near the end of the follow-up period of this study.

The researchers found that people in the surgical and medical/lifestyle groups began using GLP-1 agonist medications at similar rates during the follow-up period, and they acknowledge in their published paper that use of these drugs could have influenced the results.

Asking what role these new drugs will play in the long-term treatment of obesity and diabetes is “the million-dollar question,” Courcoulas said.

“We can see that the degrees of weight loss achieved in trials of these drugs are good and are starting to approach surgical results,” she said. “When I look at the excitement and interest in these drugs, it kind of reminds me of when bariatric surgery was 15 or 20 years ago, where short-term studies were showing incredible improvement in type 2 diabetes, and the question at the time was: “OK, great, but does it last over time?” And so I think we have the same questions for medications.

“What I would say to a patient today is, ‘All treatment options are on the table,’” Courcoulas said. “The foundation is lifestyle, diet and exercise.”

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