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Comparative Study
. 2024 Feb 27;331(8):654-664.
doi: 10.1001/jama.2024.0318.

Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes

Anita P Courcoulas  1 , Mary Elizabeth Patti  2 , Bo Hu  3 , David E Arterburn  4 , Donald C Simonson  5 , William F Gourash  1 , John M Jakicic  6 , Ashley H Vernon  7 , Gerald J Beck  3 , Philip R Schauer  8 , Sangeeta R Kashyap  9 , Ali Aminian  10 , David E Cummings  11 , John P Kirwan  12
Affiliations
Comparative Study

Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes

Anita P Courcoulas et al. JAMA. .

Abstract

Importance: Randomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration.

Objective: To determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes.

Design, setting, and participants: ARMMS-T2D (Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes) is a pooled analysis from 4 US single-center randomized trials conducted between May 2007 and August 2013, with observational follow-up through July 2022.

Intervention: Participants were originally randomized to undergo either medical/lifestyle management or 1 of the following 3 bariatric surgical procedures: Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding.

Main outcome and measures: The primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 7 years for all participants. Data are reported for up to 12 years.

Results: A total of 262 of 305 eligible participants (86%) enrolled in long-term follow-up for this pooled analysis. The mean (SD) age of participants was 49.9 (8.3) years, mean (SD) body mass index was 36.4 (3.5), 68.3% were women, 31% were Black, and 67.2% were White. During follow-up, 25% of participants randomized to undergo medical/lifestyle management underwent bariatric surgery. The median follow-up was 11 years. At 7 years, HbA1c decreased by 0.2% (95% CI, -0.5% to 0.2%), from a baseline of 8.2%, in the medical/lifestyle group and by 1.6% (95% CI, -1.8% to -1.3%), from a baseline of 8.7%, in the bariatric surgery group. The between-group difference was -1.4% (95% CI, -1.8% to -1.0%; P < .001) at 7 years and -1.1% (95% CI, -1.7% to -0.5%; P = .002) at 12 years. Fewer antidiabetes medications were used in the bariatric surgery group. Diabetes remission was greater after bariatric surgery (6.2% in the medical/lifestyle group vs 18.2% in the bariatric surgery group; P = .02) at 7 years and at 12 years (0.0% in the medical/lifestyle group vs 12.7% in the bariatric surgery group; P < .001). There were 4 deaths (2.2%), 2 in each group, and no differences in major cardiovascular adverse events. Anemia, fractures, and gastrointestinal adverse events were more common after bariatric surgery.

Conclusion and relevance: After 7 to 12 years of follow-up, individuals originally randomized to undergo bariatric surgery compared with medical/lifestyle intervention had superior glycemic control with less diabetes medication use and higher rates of diabetes remission.

Trial registration: ClinicalTrials.gov Identifier: NCT02328599.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Courcoulas reported receiving grants from Alllurion and Eli Lilly outside the submitted work. Dr Patti reported receiving grants from National Institutes of Health during the conduct of the study and grants from Dexcom; personal fees from Hanmi, MBX, and AstraZeneca; and serving on a data and safety monitoring board from Fractyl outside the submitted work. Dr Hu reported receiving grants from NIH/NIDDK during the conduct of the study. Dr Arterburn reported receiving grants from NIDDK during the conduct of the study and grants from NIH, PCORI, and Sharecare and nonfinancial support from American Society of Metabolic and Bariatric Surgery for travel outside the submitted work. Dr Simonson reported receiving grants from NIH/NIDDK during the conduct of the study and being a stockholder/shareholder in GI Windows outside the submitted work. Dr Gourash reported receiving grants from NIH/NIDDK during the conduct of the study. Dr Jakicic reported receiving personal fees from Wondr Health, Education Initiatives, WW International, and Epitomee Medical outside the submitted work. Dr Beck reported receiving grants from NIDDK and NHLBI during the conduct of the study. Dr Schauer reported receiving grants from NIDDK/NIH during the conduct of the study and personal fees from GI Dynamics, Persona, Mediflix, Metabolic Health Institute, Lilly, SE Healthcare, lder, grants from Ethicon, personal fees from Ethicon Honoraria for speaking, grants from Medtronic, personal fees from Medtronic Honoraria for speaking, personal fees from Novo Nordisk Honoraria for speaking, and personal fees from Heron Advisory Board outside the submitted work. Dr Kashyap reported receiving nonfinancial support from Fractyl Laboratories, personal fees from GI Dynamics, and serving as contractual chief medical officer for Gila Therapeutics outside the submitted work. Dr Aminian reported receiving grants and personal fees from Medtronic, Eli Lilly, and Ethicon outside the submitted work. Dr Cummings reported serving on scientific advisory boards of GI Dynamics, Endogenex, and Gila Pharmaceuticals. Dr Kirwan reported grants from NIH/NIDDK U01 DK114156 during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Assembly of the Trials in the Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D)
aThree participants who were lost to follow-up in the original trials were successfully rerecruited into ARMMS-T2D.8
Figure 2.
Figure 2.. HbA1c and Weight Loss by Group and Procedure Type
The lines and dots represent the least-square estimates obtained from the model and the boxplots represent the raw data. Horizonal lines within the boxes demonstrate median values, dots indicate mean values, the tops and bottoms of the boxes represent the IQR, and the whiskers represent the highest and lowest values within 1.5 × the IQR.
Figure 3.
Figure 3.. Diabetes Remission
Remission was defined as hemoglobin A1c less than 6.5% and not receiving any medications for diabetes.
See this image and copyright information in PMC

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