Long-term Adverse Effects After Bariatric Surgery on Bone Density (FUB-A)

University Hospital Basel

Status: Completed

Conditions: Morbid Obesity

Treatments: Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)

Study type: Interventional

Funder types: Other

Identifiers

NCT03410459

FUB Study Bone

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Gastric Bypass

Active Comparator group

Description:

Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density

Treatment:

Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)

Sleeve gastrectomy

Active Comparator group

Description:

Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density

Treatment:

Diagnostic Test: DEXA (= Dual-energy x-ray absorptiometry)