Long-term Adverse Effects After Bariatric Surgery on Bone Density

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)

• Registration Number: NCT03410459
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Detailed Description

Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: data on alterations in bone health are missing,

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Study Start: 2018-02-02
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients who received laparoscopic sleeve gastrectomy (LSG) or laparoscopic gastric bypass (LRYGB) ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.

Exclusion Criteria

• LSG or LRYGB as a secondary bariatric procedure (e.g. after gastric banding), patients receiving secondary bariatric operation after LSG resp LRYGB (e.g. biliopancreatic diversion), pregnancy (due to radiation exposition)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastric Bypass	DEXA (= Dual-energy x-ray absorptiometry)	Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density
Sleeve gastrectomy	DEXA (= Dual-energy x-ray absorptiometry)	Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density

Primary Outcome Measures

Name	Time	Method
Total hip T-Score measured with dual-energy x-ray absorptiometry	5-7 years after bariatric surgery	measured score will be compared to reference score for this age

Secondary Outcome Measures

Name	Time	Method
Total vertebral T-Score measured with dual-energy x-ray absorptiometry	5-7 years after bariatric surgery	measured score will be compared to reference score for this age
fracture risk assessed by FRAX score	5-7 years after bariatric surgery	measured score will be compared to reference score for this age
plasma concentration of C-terminal telopeptide (CTX)	5-7 years after bariatric surgery	measured plasma concentration will be compared to reference for this age
plasma concentration of vitamin D3	5-7 years after bariatric surgery	measured plasma concentration will be compared to reference for this age

Trial Locations

Locations (1)

St Claraspital; 🇨🇭 Basel, Switzerland