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

This study has been completed.
University Hospital Koge
Information provided by (Responsible Party):
Bolette Hartmann, University of Copenhagen Identifier:
First received: October 2, 2012
Last updated: December 16, 2014
Last verified: December 2014
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
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:

Further study details as provided by Bolette Hartmann, 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. ]

Secondary Outcome Measures:
  • 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.

Enrollment: 18
Study Start Date: October 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (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.


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.

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
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Please refer to this study by its identifier: NCT01700686

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

Responsible Party: Bolette Hartmann, PhD, University of Copenhagen Identifier: NCT01700686     History of Changes
Other Study ID Numbers: GBPK
Study First Received: October 2, 2012
Last Updated: December 16, 2014

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 25, 2017