Skip to main content
OpenTrials
Completed

NCT Number: NCT03410459

Long-term Adverse Effects After Bariatric Surgery on Bone Density

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Claraspital

Basel, 4016, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DEXA (= Dual-energy x-ray absorptiometry)

Diagnostic Test

measurement of vertebral bone and hip bone mineral density

Primary outcomes

  1. Total hip T-Score measured with dual-energy x-ray absorptiometry

    Time frame: 5-7 years after bariatric surgery

    measured score will be compared to reference score for this age

Secondary outcomes

  1. Total vertebral T-Score measured with dual-energy x-ray absorptiometry

    Time frame: 5-7 years after bariatric surgery

    measured score will be compared to reference score for this age

  2. fracture risk assessed by FRAX score

    Time frame: 5-7 years after bariatric surgery

    measured score will be compared to reference score for this age

  3. plasma concentration of C-terminal telopeptide (CTX)

    Time frame: 5-7 years after bariatric surgery

    measured plasma concentration will be compared to reference for this age

  4. plasma concentration of vitamin D3

    Time frame: 5-7 years after bariatric surgery

    measured plasma concentration will be compared to reference for this age

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part A)

Acronym: FUB-A

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2018
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.