The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.

December 16, 2014 updated by: Bolette Hartmann, University of Copenhagen
The overall purpose is to explore the link between the gut and the bones by investigating meal stimulated changes in the blood level of a number of hormones and markers related to intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric bypass). The hormones will be measured in blood samples taken before and after surgery. The results are compared with changes in body weight and body composition as measured by DEXA scanning.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

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

  • Denmark
      • Koege, Denmark, DK-4600
        • Hospital of Roskilde-Koege, The University of Copenhagen

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are recruited from The Bariatric Clinic, The Hospital of Roskilde-Koege, The University of Copenhagen.

Description

Inclusion Criteria:

  • Caucasians fulfilling the criteria for laparoscopic gastric bypass.
  • BMI>40kg/m2.

Exclusion Criteria:

  • Pregnancy
  • Chronic obstructive pulmonary disease
  • Diabetes mellitus
  • Chronic inflammatory bowel disease
  • Major psychiatric disorder
  • Drug abuse

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
Obese subjects
Meal test and dexa scan
Other: Meal test and dexa scan
Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Meal stimulated changes in gut hormones and bone markers.
Time Frame: Before surgery and 4 weeks and 6 months after surgery.
Before surgery and 4 weeks and 6 months after surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in bone mass and body composition.
Time Frame: Before surgery and 6 months after surgery.
Before surgery and 6 months after surgery.

Collaborators and Investigators

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

Sponsor

University of Copenhagen

Collaborators

Zealand 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

October 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • GBPK

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.

Clinical Trials on Obesity

Clinical Trials on Meal test and dexa scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe