Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: The diabetes surgery study randomized clinical trial

Sayeed Ikramuddin, Judith Korner, Wei Jei Lee, John E. Connett, William B. Inabnet, Charles J. Billington, Avis J. Thomas, Daniel B. Leslie, Keong Chong, Robert W. Jeffery, Leaque Ahmed, Adrian Vella, Lee Ming Chuang, Marc Bessler, Michael G. Sarr, James M. Swain, Patricia Laqua, Michael Dennis Jensen, John P. Bantle

Research output: Contribution to journalArticle

429 Citations (Scopus)

Abstract

Importance: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. Objective: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. Design, Setting, and Participants: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Interventions: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Main Outcomes and Measures: Composite goal of HbA 1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. Results: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. Conclusions and Relevance: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.

Original languageEnglish (US)
Pages (from-to)2240-2249
Number of pages10
JournalJAMA - Journal of the American Medical Association
Volume309
Issue number21
DOIs
StatePublished - 2013

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Gastric Bypass
Hyperlipidemias
Type 2 Diabetes Mellitus
Life Style
Randomized Controlled Trials
Hypertension
Blood Pressure
compound A 12
C-Peptide
Dyslipidemias
Taiwan
Teaching Hospitals
Malnutrition
Hyperglycemia
LDL Cholesterol
Weight Loss
Hemoglobins
Body Mass Index
Odds Ratio
Cholesterol

ASJC Scopus subject areas

  • Medicine(all)

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Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia : The diabetes surgery study randomized clinical trial. / Ikramuddin, Sayeed; Korner, Judith; Lee, Wei Jei; Connett, John E.; Inabnet, William B.; Billington, Charles J.; Thomas, Avis J.; Leslie, Daniel B.; Chong, Keong; Jeffery, Robert W.; Ahmed, Leaque; Vella, Adrian; Chuang, Lee Ming; Bessler, Marc; Sarr, Michael G.; Swain, James M.; Laqua, Patricia; Jensen, Michael Dennis; Bantle, John P.

In: JAMA - Journal of the American Medical Association, Vol. 309, No. 21, 2013, p. 2240-2249.

Research output: Contribution to journalArticle

Ikramuddin, S, Korner, J, Lee, WJ, Connett, JE, Inabnet, WB, Billington, CJ, Thomas, AJ, Leslie, DB, Chong, K, Jeffery, RW, Ahmed, L, Vella, A, Chuang, LM, Bessler, M, Sarr, MG, Swain, JM, Laqua, P, Jensen, MD & Bantle, JP 2013, 'Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: The diabetes surgery study randomized clinical trial', JAMA - Journal of the American Medical Association, vol. 309, no. 21, pp. 2240-2249. https://doi.org/10.1001/jama.2013.5835
Ikramuddin, Sayeed ; Korner, Judith ; Lee, Wei Jei ; Connett, John E. ; Inabnet, William B. ; Billington, Charles J. ; Thomas, Avis J. ; Leslie, Daniel B. ; Chong, Keong ; Jeffery, Robert W. ; Ahmed, Leaque ; Vella, Adrian ; Chuang, Lee Ming ; Bessler, Marc ; Sarr, Michael G. ; Swain, James M. ; Laqua, Patricia ; Jensen, Michael Dennis ; Bantle, John P. / Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia : The diabetes surgery study randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2013 ; Vol. 309, No. 21. pp. 2240-2249.
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abstract = "Importance: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. Objective: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. Design, Setting, and Participants: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0{\%} or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Interventions: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Main Outcomes and Measures: Composite goal of HbA 1c less than 7.0{\%}, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. Results: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49{\%}; 95{\%} CI, 36{\%}-63{\%}) in the gastric bypass group and 11 (19{\%}; 95{\%} CI, 10{\%}-32{\%}) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95{\%} CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95{\%} CI for the difference, 2.3-3.6) and lost 26.1{\%} vs 7.9{\%} of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5{\%}; 95{\%} CI, 14.2{\%}-20.7{\%}). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. Conclusions and Relevance: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.",
author = "Sayeed Ikramuddin and Judith Korner and Lee, {Wei Jei} and Connett, {John E.} and Inabnet, {William B.} and Billington, {Charles J.} and Thomas, {Avis J.} and Leslie, {Daniel B.} and Keong Chong and Jeffery, {Robert W.} and Leaque Ahmed and Adrian Vella and Chuang, {Lee Ming} and Marc Bessler and Sarr, {Michael G.} and Swain, {James M.} and Patricia Laqua and Jensen, {Michael Dennis} and Bantle, {John P.}",
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T1 - Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia

T2 - The diabetes surgery study randomized clinical trial

AU - Ikramuddin, Sayeed

AU - Korner, Judith

AU - Lee, Wei Jei

AU - Connett, John E.

AU - Inabnet, William B.

AU - Billington, Charles J.

AU - Thomas, Avis J.

AU - Leslie, Daniel B.

AU - Chong, Keong

AU - Jeffery, Robert W.

AU - Ahmed, Leaque

AU - Vella, Adrian

AU - Chuang, Lee Ming

AU - Bessler, Marc

AU - Sarr, Michael G.

AU - Swain, James M.

AU - Laqua, Patricia

AU - Jensen, Michael Dennis

AU - Bantle, John P.

PY - 2013

Y1 - 2013

N2 - Importance: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. Objective: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. Design, Setting, and Participants: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Interventions: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Main Outcomes and Measures: Composite goal of HbA 1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. Results: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. Conclusions and Relevance: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.

AB - Importance: Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. Objective: To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. Design, Setting, and Participants: A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. Interventions: Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. Main Outcomes and Measures: Composite goal of HbA 1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. Results: All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. Conclusions and Relevance: In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.

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