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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Placebo + GLP-2; Other: Placebo + Saline; Other: Inhibitor + GLP-2; Other: Placebo + GIP

• Registration Number: NCT03159741
• Lead Sponsor: University of Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-16
• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo + GLP-2	Placebo + GLP-2	-
Placebo + Saline	Placebo + Saline	-
Inhibitor + GLP-2	Inhibitor + GLP-2	-
Placebo + GIP	Placebo + GIP	-

Primary Outcome Measures

Name	Time	Method
C-terminal telopeptide (CTX)	-30 to 240 min.	Marker of bone resorption

Secondary Outcome Measures

Name	Time	Method
Glucose	-30 to 240 min.
Osteoprotegerin (OPG)	-30 to 240 min.	Bone marker
Osteocalcin (OC)	-30 to 240 min.	Bone marker
Parathyroid hormone (PTH)	-30 to 240 min.	Bone marker
Glucose-dependent insulinotropic polypeptide (GIP)	-30 to 240 min.	GIP total and intact
Glukagon-like peptide-1 (GLP-1) and glukagon-like peptide-2 (GLP-2)	-30 to 240 min.
N-terminal propeptide of type 1 procollagen (P1NP)	-30 to 240 min.	Marker of bone formation
Glukagon and pancreatic polypeptide (PP)	-30 to 240 min.
Insulin/c-pep.	-30 to 240 min.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark