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NCT03159741 Clinical Trial

Investigation of GLP-2 Mechanism of Action (GA-8)

Healthy Clinical Trial

Official title:
Investigation of GLP-2 Mechanism of Action (GA-8)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03159741
Other study ID # GA-8-2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 16, 2017
Est. completion date September 29, 2017

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

Glucagon-like peptide-2 (GLP-2) is a naturally occuring hormone secreted to the circulation in response to food ingestion. Previous studies have shown that GLP-2 and incretins inhibit the bone resorption. However, the mechanism is unknown. In the present study we will investigate the mechanism of action using a receptor specific inhibitor.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date September 29, 2017
Est. primary completion date September 29, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy, 20 to 40 years old, caucasian, BMI 18,5 to 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:
• Inhibitor + GLP-2
Inhibitor and GLP-2 are used as study tools.
• Placebo + GLP-2
Placebo and GLP-2 are used as study tools.
• Placebo + GIP
Placebo and GIP are used as study tools.
• Placebo + Saline
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
Primary C-terminal telopeptide (CTX) Marker of bone resorption -30 to 240 min.
Secondary N-terminal propeptide of type 1 procollagen (P1NP) Marker of bone formation -30 to 240 min.
Secondary Osteocalcin (OC) Bone marker -30 to 240 min.
Secondary Parathyroid hormone (PTH) Bone marker -30 to 240 min.
Secondary Osteoprotegerin (OPG) Bone marker -30 to 240 min.
Secondary Glucose-dependent insulinotropic polypeptide (GIP) GIP total and intact -30 to 240 min.
Secondary Glukagon-like peptide-1 (GLP-1) and glukagon-like peptide-2 (GLP-2) -30 to 240 min.
Secondary Glukagon and pancreatic polypeptide (PP) -30 to 240 min.
Secondary Glucose -30 to 240 min.
Secondary Insulin/c-pep. -30 to 240 min.
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