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NCT03573934 Clinical Trial

Gut Hormones and Bone Remodeling in Humans (KS-2)

Healthy Clinical Trial

— KS-2  

Official title:
Investigation of GLP-2 Mechanism of Action (KS-2)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03573934
Other study ID # UCHP-KS-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2017
Est. completion date March 15, 2018

Study information
Verified date January 2020
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effects of GLP-2 and GIP on bone remodeling in healthy young men.

Description:

We will investigate acute effects of GLP-2 and GIP on bone remodeling in healthy young men.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 15, 2018
Est. primary completion date March 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

Age between 20 and 40 years old Caucasian Healthy BMI between 18.5 and 24.9 kg/m2.

Exclusion Criteria:

Chronic disease Smoking Medication Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb<8,0 mmol/L Decreased renal function.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• GLP-2
GLP-2
• GIP
GIP
• GLP-2+GIP
GLP-2+GIP
• Placebo
Placebo

Locations
Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (2)
Lead Sponsor Collaborator
University of Copenhagen Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Heart rate Before blood sampling From -10 minutes to 240 minutes.
Other Blood pressure Before blood sampling From -10 minutes to 240 minutes.
Primary Bone resorption C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum. From -10 minutes to 240 minutes.
Primary Bone formation P1NP is a marker of bone formation. Measured in serum. From -10 minutes to 240 minutes.
Secondary Parathyroid hormone PTH is a bone marker From -10 minutes to 240 minutes.
Secondary Calcium Measured in serum. From -10 minutes to 240 minutes.
Secondary GIP Intact and total GIP. From -10 minutes to 240 minutes.
Secondary GLP-2 Intact GLP-2 From -10 minutes to 240 minutes.
Secondary Glucose Measured in serum. From -10 minutes to 240 minutes.
Secondary Insulin Measured in serum. From -10 minutes to 240 minutes.
Secondary C-peptide Measured in serum. From -10 minutes to 240 minutes.
Secondary Sclerostin Bone marker. From -10 minutes to 240 minutes.
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