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NCT03574064 Clinical Trial

Effects of Gut Peptides on Bone Remodeling

Healthy Clinical Trial

— KS-3  

Official title:
Investigation of GLP-2 Mechanism of Action

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03574064
Other study ID # UCPH-KS-3-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date January 1, 2019

Study information
Verified date January 2021
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We will investigate effects of gut hormones on bone remodeling.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date January 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: Women Age above 50 years Postmenopausal Caucasian BMI 18.5 to 28.0 kg/m2. Exclusion Criteria: Smoking Medication believed to influence study outcome Weight change more than 3 kg whitin the last 3 months Overweight surgery Intestinal surgery Hgb<7,0 mmol/L Decreased renal function

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Glucagon-Like Peptide-2 (GLP-2)
Glucagon-Like Peptide-2 (GLP-2) injection.
• Glucose-dependent insulinotropic polypeptide (GIP)
Glucose-dependent insulinotropic polypeptide (GIP) injection.
• GLP-2+GIP
GLP-2+GIP injection.
• Placebo
Placebo injection.

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 Blood pressure Measured before blood sampling. -10 minutes to 60 minutes
Other Heart rate Measured before blood sampling. -10 minutes to 60 minutes
Primary C-terminal telopeptide (CTX). At all time points and AUC(0-240 min). CTX is a marker of bone resorption. Measured in serum. -10 minutes to 600 minutes
Primary N-terminal propeptide of type 1 procollagen (P1NP). At all time points and AUC(0-240 min). P1NP is a marker of bone formation. Measured in serum. -10 minutes to 600 minutes
Secondary PTH Bone marker. Measured in serum. -10 minutes to 600 minutes
Secondary Sclerostin Bone marker. -10 minutes to 600 minutes
Secondary Calcium Measured in serum within 5 days. -10 minutes to 600 minutes
Secondary Glucose Measured in serum. -10 minutes to 600 minutes
Secondary Glucose-dependent insulinotropic polypeptide (GIP) Total and intact GIP. Measured in plasma. -10 minutes to 600 minutes
Secondary Insulin Measured in serum. -10 minutes to 600 minutes
Secondary C-peptide Measured in serum. -10 minutes to 600 minutes
Secondary Glukagon-like peptide-1 (GLP-1) Measured in plasma. -10 minutes to 600 minutes
Secondary Glucagon Measured in plasma. -10 minutes to 600 minutes
Secondary Glukagon-like peptide-2 (GLP-2) Intact GLP-2. Measured in plasma. -10 minutes to 600 minutes
Secondary PP Measured in plasma. -10 minutes to 600 minutes
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