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Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women

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clinicaltrials.gov/study/NCT06547515
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT065475150
Health Conditions in Trial
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Bone health
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Bariatric surgery
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Trial Recruitment Size
1560
Clinical Trial Start Date
September 14, 2022
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Primary Completion Date
August 15, 2026
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Study Completion Date
August 15, 2026
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Clinical Trial Study Type
Observational0
Intervention Type
Procedure0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Official Name
Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women0
Last Updated
August 9, 2024
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Other attributes

Intervention Treatment
Bariatric surgery0
Study summary

Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.

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