Pennington Biomedical’s Dr. John Kirwan and Dr. Philip Schauer Among the Key Investigators for the 12-Year Study on the Impact of Bariatric Surgery on Type 2 Diabetes

Baton Rouge, LA, February 29, 2024 --(PR.com)-- People with type 2 diabetes who underwent bariatric surgery achieved much better long-term blood glucose control compared to people who received medical management plus lifestyle interventions, according to a study published in JAMA and funded by the National institute of Diabetes, Digestive and Kidney Diseases.

In addition, participants who underwent bariatric surgery were more likely to stop needing diabetes medications and had higher rates of diabetes remission up to 12 years post-surgery. Pennington Biomedical’s Dr. John Kirwan and Dr. Philip Schauer were among the lead investigators for the 12-year study.

“This is the largest and longest running study of its kind, and it provides the key insight that metabolic surgery provides better long-term remission of type 2 diabetes over standard management of the disease,” said Dr. Kirwan, Executive Director of Pennington Biomedical. “As Principal Investigator of this multicenter trial, I am so proud of the outstanding team effort that brought together scientists from Pennington Biomedical, Cleveland Clinic, Harvard, Pittsburgh and Seattle to collaborate and contribute to this milestone study.”

The study combined independent single-center randomized trial data from four centers in the U.S. – Cleveland Clinic, Joslin Diabetes Center/Brigham and Women’s Hospital, University of Pittsburgh, and University of Washington. The original trials evaluated the effectiveness of bariatric surgery compared to intensive lifestyle and medication therapy involving oral and injectable diabetes medications including insulin for adults with type 2 diabetes and overweight or obesity.

While some participants in the study were prescribed GLP-1 agonists as part of their medical management of diabetes, these drugs were not specifically examined in the study. The investigators from the four individual studies pooled their data to provide a larger and more geographically diverse data set to evaluate efficacy, durability, and safety of bariatric surgery to treat type 2 diabetes. Follow-up data were collected through July 2022.

In total, 262 participants from the four original studies enrolled in the current study. Of these, 166 were randomized to surgery and had undergone one of three common bariatric surgery procedures: sleeve gastrectomy, gastric bypass and gastric banding. The remaining 96 participants were randomized to the medical/lifestyle management group. Participants in the lifestyle interventions received treatments that have previously been shown to be effective for weight loss. All participants were between the ages 18 and 65 and had overweight or obesity as measured by body mass index, or BMI. Primary endpoint results were measured at seven years, with continued follow-up through 12 years.

At seven years, participants in the surgery group experienced an average 20 percent weight loss compared to 8 percent in the medical/lifestyle group. The surgery group had greater improvements in blood glucose control, measured by HbA1c, with 54 percent of participants in the surgery group achieving an HbA1c of less than 7 percent compared to only 27 percent of participants in the medical/lifestyle group. More participants with surgery achieved diabetes remission compared to participants the medication/lifestyle group, and the percent of participants using medications to treat diabetes in the surgery group decreased from 98 percent to 61 percent yet remained largely unchanged in the medication/lifestyle group.

The results and differences between groups remained significant at 12 years.

“We are pleased to have taken part in this landmark study, and these results further reinforce the confidence we have in metabolic surgery,” said Dr. Schauer, Director of the Metamor Metabolic Institute at Pennington Biomedical. Dr. Schauer, a metabolic surgeon, performed the surgery on these patients, while at his former position at the Cleveland Clinic. “For patients with type 2 diabetes and obesity, who are at serious risk of heart attack, stroke, premature death, or diabetes complications, metabolic surgery, especially gastric bypass or sleeve gastrectomy, is safe, well established and an effective life changing option for many.”

Additional exploratory analyses in this study showed that bariatric surgery had important, beneficial effects on HbA1c and weight loss among participants with a BMI between 27 and 34 (within overweight and lower obesity ranges).

Study participant Judge Parker underwent bariatric surgery in December 2008 by Dr. Schauer. Since the surgery, and with regular check-ups, he now weighs 195 pounds, dropping from 306 pounds prior to the surgery. Additionally, Parker is diabetes free, is not taking any diabetes medication and has an A1C level of 5.6 percent.

“The surgery was my lifesaver,” Parker said. “I was on diabetes medicines and insulin, but I mostly remember I had a hard time getting around, I got tired and simply didn’t feel good. Now, I’m rearing to go, over 100 pounds lighter and free of diabetes, sleep apnea and lower blood pressure.”

The study, known as the “Alliance of Randomized Trials of Medicine vs. Metabolic Surgery in Type 2 Diabetes” is supported by cooperative agreement U01DK114156 from NIH National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK.