February 28, 2024 – When Kristen Hugus was offered the chance to take part in a medical trial that may randomly assign individuals with type 2 diabetes to either bariatric surgery or intensive lifestyle coaching plus medication, she considered her 4 yr old daughter.
“I was just so tired all the time, and I remember the summer before this all happened to me, lying on the couch and it was a beautiful day outside and my daughter really wanted to do things that I just didn't had the energy,” she remembers. “Although the prospect of potentially major surgery was scary, I couldn't pass up the opportunity to be healthy because I wanted to be a good role model for my daughter. ”
Hugus was randomly assigned to undergo gastric bypass surgery, sometimes called weight reduction surgery, for the study. That was in 2010, and shortly after, she not needed to make use of insulin to regulate her blood sugar, and her blood sugar levels on the commonly used A1c test fell right into a much safer range. Over time, the 5-foot-10, 5-inch-tall registered nurse's weight decreased by 33 percent, from 188 kilos to about 125 kilos.
Hugus is now 50 years old and lives in a suburb outside of Pittsburgh. He has been cultivating these health advantages for greater than 10 years. Their results largely reflect the general results of the study published Tuesday in The Journal of the American Medical Association.
Researchers reported that the 166 patients who underwent bariatric surgery were significantly more prone to experience improved blood sugar control, diabetes remission, reduced levels of cholesterol, and far of their weight reduction for a dozen years than the 96 individuals who were treated with medical treatment and lifestyle changes based on approaches called Look AHEAD and the Diabetes Prevention Program. This is the longest follow-up comparison up to now of individuals with type 2 diabetes randomized to treatment with bariatric surgery versus medical treatment/lifestyle. All people within the study initially had type 2 diabetes and were either obese or obese.
The study answers a long-standing query about whether surgical results are everlasting, much like current questions on blockbuster weight reduction drugs and whether or not they provide lasting results.
Individuals whose treatment included lifestyle interventions received intensive dietary and behavioral counseling for no less than one yr. People within the surgery group had considered one of three kinds of bariatric surgery: gastric bypass, sleeve gastrectomy or banding, the latter of which is not any longer commonly used. Bariatric surgeries They change the stomach or small intestine and affect what number of calories an individual can devour or absorb.
After seven years, 18% of surgery patients had achieved diabetes remission, compared with 6% of those within the medical/lifestyle group. But after 12 years, nobody in the approach to life group was in remission, while 13% within the surgery group remained so. But the remission rate within the surgery group was much higher after the primary yr (almost 51%), and within the medical/lifestyle group, in contrast, the remission rate improved from lower than 1% after the primary yr.
This suggests “that bariatric surgery is an effective intervention for better diabetes management, but the effects are not as lasting as had been hoped,” Dr. Neda Rasouli, director of the Diabetes and Endocrinology Clinical Trial Program on the University of Colorado School of Medicine, said in an email. She was not involved within the study.
People in the approach to life group were also treated with medication. Before surgery, just about all people within the surgery group were also taking medication for diabetes, but one yr after surgery only 38% were still taking medication, although that proportion increased to 61% after seven years.
“So that’s really important to highlight. It cannot be said that surgery will free everyone from all medications forever. “Surgery leads to an improvement in blood sugar control and an improvement in diabetes remission, and that improvement, as other studies have shown quite clearly, has some sort of after-effects,” said the study’s lead writer, Dr. Anita P. Courcoulas, professor of surgery on the University of Pittsburgh School of Medicine. “So if you have just a short period of diabetes remission and improved blood sugar control, you are likely to increase your chance of not developing microvascular and macrovascular diabetes complications such as heart attack, stroke, eye, foot and kidney complications.”
However, Rasouli noted that the study didn't discover a reduced risk of problems with the guts and blood vessels amongst people within the surgery group, although this will likely have been as a result of some design elements of the study.
After 12 years, researchers reported that the common sustained weight reduction was 19% in surgical patients and 11% in medical/lifestyle patients.
Importantly, researchers were capable of study a subgroup of individuals with lower body mass indices, or BMIs (as much as 30), and located that this lower BMI group had similarly higher outcomes after bariatric surgery in comparison with the medical/lifestyle approach . (BMI is a measure of an individual's body fat percentage based on height and weight.)
Groundbreaking latest treatments using a category of medication called GLP-1 agonists weren't a significant a part of the study because research began between 2007 and 2013, before these latest drugs, reminiscent of Ozempic and Mounjaro, became popular.
However, since the follow-up period of this study was so long, many patients in each treatment groups eventually began taking GLP-1 agonist drugs.
The study is referred to 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 began with 4 separate but similar studies that were later combined for evaluation. The 4 research centers involved within the project were the University of Pittsburgh, Cleveland Clinic, Joslin Diabetes Center and Brigham and Women's Hospital, in addition to the University of Washington and Kaiser Permanente Washington.
Because the study involved 4 separate studies, there are some limitations to the outcomes, Rasouli said, reminiscent of the treatment approaches are usually not 100% similar and the follow-up periods are different. Compared to those within the surgery group, fewer people within the medical/lifestyle group participated within the long-term follow-up.
“Typically, participants who did not respond well to the intervention are more likely to not participate in long-term follow-up,” she said.
While people within the surgery group tended to have higher health outcomes, they were more likely than people within the medical/lifestyle group to experience adversarial events reminiscent of anemia, fractures and bowel problems after surgery. The problems are usually not considered serious by the medical community. But Courcoulas noted, “They are definitely important to a patient because they can cause symptoms in a patient.”
Tracking these unintended effects allows providers to tell patients upfront about what might occur after surgery, said Courcoulas, who can also be chief of minimally invasive bariatric and general surgery on the University of Pittsburgh Medical Center.
Hugus said she was well educated about what to anticipate and how one can reduce the danger of those problems after her gastric bypass surgery. She has completely modified her eating habits.
“A lot has changed for me mentally and physically. I have a physical barrier that if I eat too much I don't feel good. But psychologically, it made me really aware of portion sizes and how much we all really eat, and it gave me perspective on how to eat better,” she said.
“For example, I knew that if I ate too much too quickly or had too many carbohydrates, I could get what's called dumping syndrome, which is basically very rapid diarrhea that you just don't know about “That he's coming.” “Explained Hugus. “Or if I eat too much at once, I might throw up. It was a challenge at first because it’s just a matter of getting used to your limits and listening to your body.”
Overall, about one in 4 surgical patients reported some kind of gastrointestinal problem, compared with 16% of individuals within the medical/lifestyle group.
In the medical/lifestyle group, 25% of individuals had surgery throughout the follow-up period, the researchers reported. However, additional evaluation found that the following surgery was unlikely to have dramatically affected the study's leads to changing participants' glycemic control A1c levels.
“The spectrum of treatments 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 that during the period of the study, which spanned many years … people who were not able to control their diabetes said, 'I'm going to move on to the next level of treatment.'”
She said the identical concept of adding or trying latest treatments applies to the introduction of GLP-1 agonists, which also include semaglutide and tirzepatide – known by the brand names Ozempic and Mounjaro. Towards the top of the follow-up period of this study, they were approved by the FDA for the treatment of diabetes.
The researchers found that individuals in each the surgical and medical/lifestyle groups began taking GLP-1 agonists at similar rates throughout the follow-up period, and so they acknowledge of their published work that using these Medication can have influenced the outcomes.
Asking what role these latest drugs will play within the long-term treatment of obesity and diabetes is “the million-dollar question,” Courcoulas said.
“We can see that the level of weight loss achieved in the trials for these drugs is good and is gradually approaching surgical results,” she said. “When I look at the excitement and interest in these drugs, I kind of remember bariatric surgery 15 or 20 years ago, when there were short-term studies showing incredible improvement in type 2 diabetes, and…” The query Back then it was, ‘Okay, great, but does it last long?’ And so I believe we've the identical questions on the medication.”
“What I would say to a patient today is, 'All treatment options are on the table,'” Courcoulas said. “The basis is lifestyle, diet and exercise.”