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

February 6, 2017 updated by: Kirstine Nyvold Bojsen-Moeller, Hvidovre University Hospital

Bone Mineral Density and Markers of Bone Turnover After Roux-en-Y Gastric Bypass

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from a previously investigated cohort of 20 subjects undergoing Roux-en-Y gastric bypass surgery (NCT 01202526). The previous study aimed at investigating acute and long term changes in insulin sensitivity and secretion, whereas the present follow-up study investigates changes in bone metabolism as the primary outcome.

Description

Inclusion Criteria:

  • Participation in previos study ((NCT 01202526)

Exclusion Criteria:

  • Treatment of osteoporosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RYGB patients with preoperative type diabetes
Recruited from a previously investigated cohort (NCT 01202526)
Procedure: Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery for morbid obesity
RYGB patients with preoperative normal glucose tolerance
Recruited from a previously investigated cohort (NCT 01202526)
Procedure: Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery for morbid obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in bone mineral density of non-weight bearing bone
Time Frame: 1 year, 4 years
DXA scans of forearm
1 year, 4 years
Changes in bone mineral density of weightbearing bone
Time Frame: 1 year, 4 years
DXA scans of hip and lumbal columna
1 year, 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma markers of bone turnover
Time Frame: 1 week, 3 months, 1 year, 4 years
At fasting
1 week, 3 months, 1 year, 4 years
Plasma markers of bone turnover
Time Frame: 3 months, 1 year, 4 years
during OGTT
3 months, 1 year, 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • KBM-IS-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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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