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

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

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 Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Diagnostic test: DEXA (= Dual-energy x-ray absorptiometry)

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4016
    • St Claraspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gastric Bypass; Patients ≥ 5 years after laparoscopic gastric bypass receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density	Diagnostic test: DEXA (= Dual-energy x-ray absorptiometry); measurement of vertebral bone and hip bone mineral density
Active Comparator: Sleeve gastrectomy; Patients ≥ 5 years after laparoscopic sleeve gastrectomy receive DEXA (= Dual-energy x-ray absorptiometry) in order to measure bone mass density	Diagnostic test: DEXA (= Dual-energy x-ray absorptiometry); measurement of vertebral bone and hip bone mineral density

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Bettina K Wölnerhanssen, MD, Clinical Research St. Claraspital Basel

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; Long Term Adverse Effects
• Other Study ID Numbers: FUB Study Bone

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No