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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01700686
Other study ID # GBPK
Secondary ID
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


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
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