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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01700686
• Other study ID #: GBPK
• Status: Completed
• Phase: N/A
• First received: October 2, 2012
• Last updated: December 16, 2014
• Start date: October 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Loss
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Denmark	Hospital of Roskilde-Koege, The University of Copenhagen	Koege

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meal stimulated changes in gut hormones and bone markers.		Before surgery and 4 weeks and 6 months after surgery.	No
Secondary	Changes in bone mass and body composition.		Before surgery and 6 months after surgery.	No