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

Sayeed Ikramuddin, Judith Korner, Wei Jei Lee, Avis J. Thomas, John E. Connett, John P. Bantle, Daniel B. Leslie, Qi Wang, William B. Inabnet, Robert W. Jeffery, Keong Chong, Lee Ming Chuang, Michael D. Jensen, Adrian Vella, Leaque Ahmed, Kumar Belani, Charles J. Billington

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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 120participantswhohad a hemoglobinA1c (HbA1c) level of 8.0%or higher and a body mass index between 30.0and 39.9 (enrolled between April 2008and December 2011)were followed up for 5 years, ending inNovember 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 100mg/dL, and systolic blood pressure less than 130mmHg at 5 years. RESULTS Of 120 participants whowere initially randomized (mean age, 49 years [SD, 8 years], 72women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristicswere 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%; P = .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%; P = .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.

Original languageEnglish (US)
Pages (from-to)266-278
Number of pages13
JournalJAMA - Journal of the American Medical Association
Volume319
Issue number3
DOIs
StatePublished - Jan 16 2018

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Gastric Bypass
Life Style
Hemoglobins
Cholesterol
Blood Pressure
Body Mass Index
Parathyroid Hormone
Taiwan
LDL Cholesterol
Type 2 Diabetes Mellitus
Pathologic Constriction
Randomized Controlled Trials
Observation

Cite this

@article{a72355ac4446439a8f58d5f3a63a135e,
title = "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",
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 120participantswhohad a hemoglobinA1c (HbA1c) level of 8.0{\%}or higher and a body mass index between 30.0and 39.9 (enrolled between April 2008and December 2011)were followed up for 5 years, ending inNovember 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 100mg/dL, and systolic blood pressure less than 130mmHg at 5 years. RESULTS Of 120 participants whowere initially randomized (mean age, 49 years [SD, 8 years], 72women [60{\%}]), 98 (82{\%}) completed 5 years of follow-up. Baseline characteristicswere 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{\%}; P = .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{\%}; P = .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.",
author = "Sayeed Ikramuddin and Judith Korner and Lee, {Wei Jei} and Thomas, {Avis J.} and Connett, {John E.} and Bantle, {John P.} and Leslie, {Daniel B.} and Qi Wang and Inabnet, {William B.} and Jeffery, {Robert W.} and Keong Chong and Chuang, {Lee Ming} and Jensen, {Michael D.} and Adrian Vella and Leaque Ahmed and Kumar Belani and Billington, {Charles J.}",
year = "2018",
month = "1",
day = "16",
doi = "10.1001/jama.2017.20813",
language = "English (US)",
volume = "319",
pages = "266--278",
journal = "JAMA - Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
number = "3",

}

TY - JOUR

T1 - 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

AU - Ikramuddin, Sayeed

AU - Korner, Judith

AU - Lee, Wei Jei

AU - Thomas, Avis J.

AU - Connett, John E.

AU - Bantle, John P.

AU - Leslie, Daniel B.

AU - Wang, Qi

AU - Inabnet, William B.

AU - Jeffery, Robert W.

AU - Chong, Keong

AU - Chuang, Lee Ming

AU - Jensen, Michael D.

AU - Vella, Adrian

AU - Ahmed, Leaque

AU - Belani, Kumar

AU - Billington, Charles J.

PY - 2018/1/16

Y1 - 2018/1/16

N2 - 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 120participantswhohad a hemoglobinA1c (HbA1c) level of 8.0%or higher and a body mass index between 30.0and 39.9 (enrolled between April 2008and December 2011)were followed up for 5 years, ending inNovember 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 100mg/dL, and systolic blood pressure less than 130mmHg at 5 years. RESULTS Of 120 participants whowere initially randomized (mean age, 49 years [SD, 8 years], 72women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristicswere 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%; P = .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%; P = .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.

AB - 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 120participantswhohad a hemoglobinA1c (HbA1c) level of 8.0%or higher and a body mass index between 30.0and 39.9 (enrolled between April 2008and December 2011)were followed up for 5 years, ending inNovember 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 100mg/dL, and systolic blood pressure less than 130mmHg at 5 years. RESULTS Of 120 participants whowere initially randomized (mean age, 49 years [SD, 8 years], 72women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristicswere 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%; P = .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%; P = .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.

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