Long-term Adverse Effects After Bariatric Surgery on Bone Density

NCT ID: NCT03410459

Last Updated: 2019-08-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-02

Study Completion Date

2019-05-30

Brief Summary

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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

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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.

Conditions

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Morbid Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gastric Bypass

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

Group Type ACTIVE_COMPARATOR

DEXA (= Dual-energy x-ray absorptiometry)

Intervention Type DIAGNOSTIC_TEST

measurement of vertebral bone and hip bone mineral density

Sleeve gastrectomy

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

Group Type ACTIVE_COMPARATOR

DEXA (= Dual-energy x-ray absorptiometry)

Intervention Type DIAGNOSTIC_TEST

measurement of vertebral bone and hip bone mineral density

Interventions

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DEXA (= Dual-energy x-ray absorptiometry)

measurement of vertebral bone and hip bone mineral density

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bettina K Wölnerhanssen, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research St. Claraspital Basel

Locations

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St Claraspital

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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FUB Study Bone

Identifier Type: -

Identifier Source: org_study_id

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