Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes
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.
| Errataetall: |
CommentIn: JAMA. 2024 Feb 27;331(8):643-645. - PMID 38411656 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:331 |
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| Enthalten in: |
JAMA - 331(2024), 8 vom: 27. Feb., Seite 654-664 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Courcoulas, Anita P [VerfasserIn] |
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| Links: |
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| Themen: |
Comparative Study |
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| Anmerkungen: |
Date Completed 28.02.2024 Date Revised 01.03.2024 published: Print ClinicalTrials.gov: NCT02328599 CommentIn: JAMA. 2024 Feb 27;331(8):643-645. - PMID 38411656 Citation Status MEDLINE |
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| doi: |
10.1001/jama.2024.0318 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369015975 |
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| 100 | 1 | |a Courcoulas, Anita P |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 28.02.2024 | ||
| 500 | |a Date Revised 01.03.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02328599 | ||
| 500 | |a CommentIn: JAMA. 2024 Feb 27;331(8):643-645. - PMID 38411656 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Importance: Randomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration | ||
| 520 | |a Objective: To determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a Trial Registration: ClinicalTrials.gov Identifier: NCT02328599 | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Meta-Analysis | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 7 | |a Glycated Hemoglobin |2 NLM | |
| 700 | 1 | |a Patti, Mary Elizabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Bo |e verfasserin |4 aut | |
| 700 | 1 | |a Arterburn, David E |e verfasserin |4 aut | |
| 700 | 1 | |a Simonson, Donald C |e verfasserin |4 aut | |
| 700 | 1 | |a Gourash, William F |e verfasserin |4 aut | |
| 700 | 1 | |a Jakicic, John M |e verfasserin |4 aut | |
| 700 | 1 | |a Vernon, Ashley H |e verfasserin |4 aut | |
| 700 | 1 | |a Beck, Gerald J |e verfasserin |4 aut | |
| 700 | 1 | |a Schauer, Philip R |e verfasserin |4 aut | |
| 700 | 1 | |a Kashyap, Sangeeta R |e verfasserin |4 aut | |
| 700 | 1 | |a Aminian, Ali |e verfasserin |4 aut | |
| 700 | 1 | |a Cummings, David E |e verfasserin |4 aut | |
| 700 | 1 | |a Kirwan, John P |e verfasserin |4 aut | |
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