The Effect of Roux-en-Y Gastric Bypass on Bone Turnover

• Conditions: Bone Loss; Obesity; Gastric Bypass Surgery
• Interventions: Procedure: Roux-en-Y gastric bypass

• Registration Number: NCT03046147
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

Bone mineral density (BMD) is decreased after Roux-en-Y gastric bypass (RYGB) but whether RYGB induces changes in BMD beyond adaptation to major weight loss is not known. We aim to investigate BMD changes in weight bearing (hip, lumbal columna) and in non-weight bearing (forearm) regions before and after maximal weight loss at 1 year and after weight stabilisation at 4 years after RYGB. Moreover, plasma markers of bone turnover will be studied at fasting and during oral glucose tolerance test.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2017-02
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-06
• Last Update Submitted: 2017-02-06
• Study First Posted: 2017-02-08
• Last Update Posted: 2017-02-08
• Primary Completion: 2017-05
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Participation in previos study ((NCT 01202526)

Exclusion Criteria

• Treatment of osteoporosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RYGB patients with preoperative type diabetes	Roux-en-Y gastric bypass	Recruited from a previously investigated cohort (NCT 01202526)
RYGB patients with preoperative normal glucose tolerance	Roux-en-Y gastric bypass	Recruited from a previously investigated cohort (NCT 01202526)

Primary Outcome Measures

Name	Time	Method
Changes in bone mineral density of non-weight bearing bone	1 year, 4 years	DXA scans of forearm
Changes in bone mineral density of weightbearing bone	1 year, 4 years	DXA scans of hip and lumbal columna

Secondary Outcome Measures

Name	Time	Method
Plasma markers of bone turnover	3 months, 1 year, 4 years	during OGTT

Trial Locations

Locations (1)

Copenhagen University hospital Hvidovre; 🇩🇰 Copenhagen, Denmark