Roux-en-Y gastric bypass versus best medical treatment for type 2 diabetes mellitus in adults with body mass index between 27 and 32 kg/m2: A 5-year randomized controlled trial

•Asians are at increased risk for developing T2DM at lower body mass index.•The effect of gastric bypass vs best medical therapy is not well-studied in Asians.•In this randomized controlled trial, surgery outperformed best medical treatment.•Greater improvements in glycaemic control and weight were...

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Published inDiabetes research and clinical practice Vol. 188; p. 109900
Main Authors Cheng, Anton, Yeoh, Ester, Moh, Angela, Low, Serena, Tan, Chun Hai, Lam, Benjamin, Sum, Chee Fang, Subramaniam, Tavintharan, Lim, Su Chi
Format Journal Article
LanguageEnglish
Published Elsevier B.V 01.06.2022
Subjects
Online AccessGet full text
ISSN0168-8227
1872-8227
1872-8227
DOI10.1016/j.diabres.2022.109900

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Abstract •Asians are at increased risk for developing T2DM at lower body mass index.•The effect of gastric bypass vs best medical therapy is not well-studied in Asians.•In this randomized controlled trial, surgery outperformed best medical treatment.•Greater improvements in glycaemic control and weight were observed after surgery.•Gastric bypass was associated with lower cost compared with medical treatment. To evaluate the effects of Roux-en-Y gastric bypass (RYGB) versus best medical treatment in Asians with type 2 diabetes mellitus (T2DM) and class I obesity. In this 5-year single-centre, open-label randomized controlled trial, participants were randomized to RYGB or medical treatment including newer classes of diabetes medications (ClinicalTrials.gov:NCT02041234). The primary endpoint was diabetes remission defined as HbA1c ≤ 6% (≤42 mmol/mol) and discontinuation of glucose-lowering medication at 12 months post-intervention and beyond. Glycaemia and weight changes were assessed. Continuous glucose monitoring was performed. Of 28 subjects randomized, 26 were analyzed in the final cohort (14 medical, 12 RYGB; age:44 ± 10 years, 34.6% males, BMI:29.4 ± 1.6 kg/m2). At 12 months, 50% of RYGB subjects achieved diabetes remission; 83% stopped all glucose-lowering medications. By year 5, 42% were in remission. None attained diabetes remission in the medical group. Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P < 0.05). Early improvements in glycaemic variability and time in range were similar in both treatment arms. Hypoglycaemia and surgical complications were observed in some RYGB subjects. Over 5 years, RYGB outperforms best medical treatment in glycemia and weight improvements for Asians with T2DM and class I obesity.
AbstractList •Asians are at increased risk for developing T2DM at lower body mass index.•The effect of gastric bypass vs best medical therapy is not well-studied in Asians.•In this randomized controlled trial, surgery outperformed best medical treatment.•Greater improvements in glycaemic control and weight were observed after surgery.•Gastric bypass was associated with lower cost compared with medical treatment. To evaluate the effects of Roux-en-Y gastric bypass (RYGB) versus best medical treatment in Asians with type 2 diabetes mellitus (T2DM) and class I obesity. In this 5-year single-centre, open-label randomized controlled trial, participants were randomized to RYGB or medical treatment including newer classes of diabetes medications (ClinicalTrials.gov:NCT02041234). The primary endpoint was diabetes remission defined as HbA1c ≤ 6% (≤42 mmol/mol) and discontinuation of glucose-lowering medication at 12 months post-intervention and beyond. Glycaemia and weight changes were assessed. Continuous glucose monitoring was performed. Of 28 subjects randomized, 26 were analyzed in the final cohort (14 medical, 12 RYGB; age:44 ± 10 years, 34.6% males, BMI:29.4 ± 1.6 kg/m2). At 12 months, 50% of RYGB subjects achieved diabetes remission; 83% stopped all glucose-lowering medications. By year 5, 42% were in remission. None attained diabetes remission in the medical group. Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P < 0.05). Early improvements in glycaemic variability and time in range were similar in both treatment arms. Hypoglycaemia and surgical complications were observed in some RYGB subjects. Over 5 years, RYGB outperforms best medical treatment in glycemia and weight improvements for Asians with T2DM and class I obesity.
To evaluate the effects of Roux-en-Y gastric bypass (RYGB) versus best medical treatment in Asians with type 2 diabetes mellitus (T2DM) and class I obesity.AIMSTo evaluate the effects of Roux-en-Y gastric bypass (RYGB) versus best medical treatment in Asians with type 2 diabetes mellitus (T2DM) and class I obesity.In this 5-year single-centre, open-label randomized controlled trial, participants were randomized to RYGB or medical treatment including newer classes of diabetes medications (ClinicalTrials.gov:NCT02041234). The primary endpoint was diabetes remission defined as HbA1c ≤ 6% (≤42 mmol/mol) and discontinuation of glucose-lowering medication at 12 months post-intervention and beyond. Glycaemia and weight changes were assessed. Continuous glucose monitoring was performed.METHODSIn this 5-year single-centre, open-label randomized controlled trial, participants were randomized to RYGB or medical treatment including newer classes of diabetes medications (ClinicalTrials.gov:NCT02041234). The primary endpoint was diabetes remission defined as HbA1c ≤ 6% (≤42 mmol/mol) and discontinuation of glucose-lowering medication at 12 months post-intervention and beyond. Glycaemia and weight changes were assessed. Continuous glucose monitoring was performed.Of 28 subjects randomized, 26 were analyzed in the final cohort (14 medical, 12 RYGB; age:44 ± 10 years, 34.6% males, BMI:29.4 ± 1.6 kg/m2). At 12 months, 50% of RYGB subjects achieved diabetes remission; 83% stopped all glucose-lowering medications. By year 5, 42% were in remission. None attained diabetes remission in the medical group. Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P < 0.05). Early improvements in glycaemic variability and time in range were similar in both treatment arms. Hypoglycaemia and surgical complications were observed in some RYGB subjects.RESULTSOf 28 subjects randomized, 26 were analyzed in the final cohort (14 medical, 12 RYGB; age:44 ± 10 years, 34.6% males, BMI:29.4 ± 1.6 kg/m2). At 12 months, 50% of RYGB subjects achieved diabetes remission; 83% stopped all glucose-lowering medications. By year 5, 42% were in remission. None attained diabetes remission in the medical group. Percentage declines in fasting plasma glucose, HbA1c and BMI were significantly greater in the RYGB arm (all P < 0.05). Early improvements in glycaemic variability and time in range were similar in both treatment arms. Hypoglycaemia and surgical complications were observed in some RYGB subjects.Over 5 years, RYGB outperforms best medical treatment in glycemia and weight improvements for Asians with T2DM and class I obesity.CONCLUSIONSOver 5 years, RYGB outperforms best medical treatment in glycemia and weight improvements for Asians with T2DM and class I obesity.
ArticleNumber 109900
Author Sum, Chee Fang
Lam, Benjamin
Tan, Chun Hai
Moh, Angela
Yeoh, Ester
Subramaniam, Tavintharan
Low, Serena
Cheng, Anton
Lim, Su Chi
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  organization: Clinical Research Unit, Khoo Teck Puat Hospital, Singapore
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Keywords Continuous glucose monitoring
Roux-en-Y gastric bypass
Type 2 diabetes mellitus
Sodium-glucose cotransporter 2 inhibitor
Glucagon-like peptide 1 receptor agonist
Class I obesity
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Snippet •Asians are at increased risk for developing T2DM at lower body mass index.•The effect of gastric bypass vs best medical therapy is not well-studied in...
To evaluate the effects of Roux-en-Y gastric bypass (RYGB) versus best medical treatment in Asians with type 2 diabetes mellitus (T2DM) and class I...
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SubjectTerms Class I obesity
Continuous glucose monitoring
Glucagon-like peptide 1 receptor agonist
Roux-en-Y gastric bypass
Sodium-glucose cotransporter 2 inhibitor
Type 2 diabetes mellitus
Title Roux-en-Y gastric bypass versus best medical treatment for type 2 diabetes mellitus in adults with body mass index between 27 and 32 kg/m2: A 5-year randomized controlled trial
URI https://www.clinicalkey.com/#!/content/1-s2.0-S0168822722007148
https://dx.doi.org/10.1016/j.diabres.2022.109900
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