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JAMA. 2018 Jan 16;319(3):266-278. doi: 10.1001/jama.2017.20813.

Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study.

Author information

1
Department of Surgery, University of Minnesota, Minneapolis.
2
Division of Endocrinology, Department of Medicine, Columbia University Medical Center, New York, New York.
3
Surgery Department, National Taiwan University Hospital, Taipei City.
4
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.
5
Optum, Eden Prairie, Minnesota.
6
Division of Endocrinology & Diabetes, Department of Medicine, University of Minnesota, Minneapolis.
7
Division of Metabolic, Endocrine and Minimally Invasive Surgery, Mount Sinai Medical Center, New York, New York.
8
Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, Minneapolis.
9
Department of Endocrinology, Min-Sheng General Hospital, Taoyuan City, Taiwan.
10
Division of Metabolism and Endocrinology, Internal Medicine Department, National Taiwan University Hospital, Taipei City.
11
Department of Medicine, Division of Endocrinology & Diabetes, Mayo Clinic, Rochester, Minnesota.
12
Department of Surgery, Harlem Hospital Center, New York, New York.
13
Department of Anesthesiology, University of Minnesota, Minneapolis.
14
Section of Endocrinology and Metabolism, Department of Medicine, Minneapolis VA Health Care System, Minneapolis.

Abstract

Importance:

The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown.

Objective:

To compare durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets.

Design, Setting, and Participants:

Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) were followed up for 5 years, ending in November 2016.

Interventions:

Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5.

Main Outcomes and Measures:

The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years.

Results:

Of 120 participants who were initially randomized (mean age, 49 years [SD, 8 years], 72 women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristics were similar between groups: mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6% (1.2) and 9.6% (1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; Pā€‰=ā€‰.01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; Pā€‰=ā€‰.002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency.

Conclusions and Relevance:

In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.

Trial Registration:

clinicaltrials.gov Identifier: NCT00641251.

PMID:
29340678
PMCID:
PMC5833547
DOI:
10.1001/jama.2017.20813
[Indexed for MEDLINE]
Free PMC Article

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