Two‐year outcomes on bone density and fracture incidence in patients with T2DM randomized to bariatric surgery versus intensive medical therapy

Objective To determine the 2‐year outcomes of Roux‐en‐Y gastric bypass (RYGB) and sleeve gastrectomy (SG) vs. intensive medical therapy (IMT) on lean body mass, total bone mass, and bone mineral density (BMD) measures from the STAMPEDE trial. Methods 54 subjects (BMI: 36 ± 1 kg/m2, age: 48 ± 4 years...

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Published inObesity (Silver Spring, Md.) Vol. 23; no. 12; pp. 2344 - 2348
Main Authors Maghrabi, Adam H., Wolski, Kathy, Abood, Beth, Licata, Angelo, Pothier, Claire, Bhatt, Deepak L., Nissen, Steven, Brethauer, Stacy A., Kirwan, John P., Schauer, Philip R., Kashyap, Sangeeta R.
Format Journal Article
LanguageEnglish
Published United States Blackwell Publishing Ltd 01.12.2015
Subjects
Adult
Bariatric Surgery - statistics & numerical data
Body Composition - physiology
Body mass index
Bone Density
Diabetes
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - surgery
Diabetes Mellitus, Type 2 - therapy
Female
Follow-Up Studies
Fractures
Fractures, Bone - epidemiology
Gastrointestinal surgery
Humans
Hyperglycemia
Hypoglycemic Agents - administration & dosage
Incidence
Male
Metabolism
Middle Aged
Obesity
Osteoporosis
Studies
Treatment Outcome
Vitamin D
Weight control
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Summary:Objective To determine the 2‐year outcomes of Roux‐en‐Y gastric bypass (RYGB) and sleeve gastrectomy (SG) vs. intensive medical therapy (IMT) on lean body mass, total bone mass, and bone mineral density (BMD) measures from the STAMPEDE trial. Methods 54 subjects (BMI: 36 ± 1 kg/m2, age: 48 ± 4 years) with type 2 diabetes (T2DM) (HbA1c: 9.7 ± 2%) were randomized to IMT, RYGB, or SG and underwent DXA at baseline and at 1 and 2 years. Results At 2 years, the reduction in BMI was similar after RYGB and SG and was greater than IMT (P < 0.001). Lean mass was reduced by ∼10%, total bone mineral content reduced by ∼8%, and hip BMD reduced by ∼9% in both surgical groups and was significantly greater than IMT despite increases in vitamin D intake in all groups. The change in hip BMD correlated with weight loss (r = 0.84, P < 0.0001) and changes in lean mass (r = 0.74, P < 0.0001) and leptin (r = 0.53, P < 0.0001). Peripheral fractures were self‐reported in RYGB (4/18 patients), SG (2/19 patients), and IMT (4/16 patients). Conclusions Surgically induced weight loss is associated with modest reductions in lean mass, bone mineral content, and BMD, despite calcium and vitamin D supplementation in patients with T2DM. Awareness for bone loss is indicated for patients undergoing bariatric procedures.
Bibliography:Drs. Kashyap and Maghrabi and the Cleveland Clinic Coordinating Center for Clinical Research had full and independent access to all of the data in the study, and Dr. Kashyap takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Kashyap, Maghrabi, Schauer, Brethauer, Bhatt, Nissen, and Pothier. Acquisition of data: Maghrabi and Kashyap. Analysis and interpretation of data: Maghrabi, Kashyap, Wolski, Schauer, Nissen, Bhatt, Kirwan, and Licata. Drafting of the manuscript: Maghrabi and Kashyap. Statistical analysis: Wolski. Obtained funding: Schauer and Kashyap.
Advisory panel of Medscape, LLC. Board member of Boston VA Research Institute, Society of Chest Pain Centers. Chair of American Heart Association Get with the Guidelines Science Subcommittee. Honoraria from the American College of Cardiology, Duke Clinical Research Institute, Slack Publications, WebMD. Research support from Amarin, AstraZeneca/Bristol‐Meyers Squibb, Eisai, Inc., Ethicon, Medtronic, Sanofi, The Medicines Company.
JPK
This research was supported by a grant from Ethicon Endo‐Surgery, American Diabetes Association, and NIH and conducted with support from the Investigator‐Initiated Study Program of LifeScan Inc. and the Cleveland Clinic. The sponsor participated in discussions regarding study design and protocol development and provided logistical support during the trial. The database, statistical analysis, and monitoring were all performed by the Cleveland Clinic Coordinating Center for Clinical Research. The manuscript was prepared by the corresponding author and modified after consultation with coauthors. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content and submission was exclusively retained by the academic authors.
Research support from Ethicon EndoSurgery. The other authors declare no conflict of interest.
Disclosure
Funding agencies
SRK
Honoraria from Covidien as a speaker and from Ethicon Endo‐Surgery as a scientific advisory board member, consultant, speaker.
PRS
Research support from Nestle, Inc., and ScottCare.
Consultant for Orexigen Therapeutics, Inc., Vivus, Inc. Unfunded research from PLx Pharma, Takeda.
SAB
Research support from Ethicon EndoSurgery, Bard‐Davol. Educational grants from Stryker Endoscopy, Gore, Baxter, Covidien, Allergan. Honoraria from Ethicon Endo‐Surgery as a scientific advisory board member, consultant, speaker. Consultant/advisory board member for RemedyMD, Stryker Endoscopy, Bard‐Davol, Gore, Barosense, Surgiquest, Carefusion.
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Author contributions
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ISSN:1930-7381
1930-739X
DOI:10.1002/oby.21150