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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital Koge
Information provided by (Responsible Party):
Bolette Hartmann, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01700686
First received: October 2, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Bone Loss
 Other: Meal test and dexa scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Meal stimulated changes in gut hormones and bone markers. [ Time Frame: Before surgery and 4 weeks and 6 months after surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in bone mass and body composition. [ Time Frame: Before surgery and 6 months after surgery. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma and serum samples are retained.


Enrollment: 18
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700686

Locations
Denmark
Hospital of Roskilde-Koege, The University of Copenhagen
Koege, Denmark, DK-4600
Sponsors and Collaborators
University of Copenhagen
University Hospital Koge
Investigators
Principal Investigator: Bolette Hartmann, PhD University of Copenhagen
  More Information

No publications provided

Responsible Party: Bolette Hartmann, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01700686     History of Changes
Other Study ID Numbers: GBPK
Study First Received: October 2, 2012
Last Updated: October 2, 2012
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013