Long-term Adverse Effects After Bariatric Surgery on Bone Density

Morbid Obesity Clinical Trial

— FUB-A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410459
• Other study ID #: FUB Study Bone
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Long Term Adverse Effects
• Morbid Obesity
• Obesity, Morbid

Intervention

Diagnostic Test:
• DEXA (= Dual-energy x-ray absorptiometry)
measurement of vertebral bone and hip bone mineral density

Locations

Country	Name	City	State
Switzerland	St Claraspital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	fracture risk assessed by FRAX score	measured score will be compared to reference score for this age	5-7 years after bariatric surgery
Secondary	plasma concentration of C-terminal telopeptide (CTX)	measured plasma concentration will be compared to reference for this age	5-7 years after bariatric surgery
Secondary	plasma concentration of vitamin D3	measured plasma concentration will be compared to reference for this age	5-7 years after bariatric surgery