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

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ClinicalTrials.gov Identifier: NCT01700686
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : December 17, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Obesity Bone Loss Other: Meal test and dexa scan

Study Design

Study Type : Observational
Actual Enrollment : 18 participants
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.
Study Start Date : October 2011
Primary Completion Date : September 2014
Study Completion Date : September 2014

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U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Meal stimulated changes in gut hormones and bone markers. [ Time Frame: Before surgery and 4 weeks and 6 months after surgery. ]

Secondary Outcome Measures :
  1. Changes in bone mass and body composition. [ Time Frame: Before surgery and 6 months after surgery. ]

Biospecimen Retention:   Samples Without DNA
Plasma and serum samples are retained.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bolette Hartmann, PhD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01700686     History of Changes
Other Study ID Numbers: GBPK
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs