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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-14

Study Completion Date

2026-08-15

Brief Summary

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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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Detailed Description

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Conditions

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Bariatric Surgery Bone Health Severe Obesity Muscle Health

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sleeve gastrectomy - Men

n = 39 men with obesity undergoing sleeve gastrectomy

Bariatric surgery

Intervention Type PROCEDURE

Sleeve gastrectomy

Sleeve gastrectomy - Premenopausal women

n = 39 premenopausal women with obesity undergoing sleeve gastrectomy

Bariatric surgery

Intervention Type PROCEDURE

Sleeve gastrectomy

Sleeve gastrectomy - Postmenopausal women

n = 39 postmenopausal women with obesity undergoing sleeve gastrectomy

Bariatric surgery

Intervention Type PROCEDURE

Sleeve gastrectomy

Obese non-surgical group

n = 39 (13 men, 13 premenopausal and 13 postmenopausal women) obese non-surgical individuals

No interventions assigned to this group

Interventions

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Bariatric surgery

Sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Men and women aged \>18 years;
* Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.
* Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) \>40 UI/L.
* Women taking oral contraceptive pills or hormone replacement therapy
* Patients with type 2 diabetes.

Exclusion Criteria

* Type 1 diabetes;
* Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)
* Metabolic bone disease other than osteoporosis or type 2 diabetes,
* Creatinine clearance \<30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;
* Weight \>204 kg (DXA weight limit) or BMI \>60 kg/m2 (upper limit to allow for QCT examination);
* Current or planned pregnancy during follow-up; breast-feeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No