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

Not Applicable

Completed

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

• Registration Number: NCT03573934
• Lead Sponsor: University of Copenhagen

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2017-09-15
• Primary Completion: 2018-03-15
• Study Completion: 2018-03-15
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIP	GIP	Glucose-dependent Insulinotropic polypeptide (GIP) injection
GLP-2	GLP-2	Glucagon-Like Peptide-2 (GLP-2) injection
GLP-2+GIP	GLP-2+GIP	GLP-2+GIP injection
Placebo	Placebo	Placebo injection

Primary Outcome Measures

Name	Time	Method
Bone resorption	From -10 minutes to 240 minutes.	C-terminal telopeptide (CTX) is a marker of bone resorption. Measured in serum.
Bone formation	From -10 minutes to 240 minutes.	P1NP is a marker of bone formation. Measured in serum.

Secondary Outcome Measures

Name	Time	Method
Calcium	From -10 minutes to 240 minutes.	Measured in serum.
GIP	From -10 minutes to 240 minutes.	Intact and total GIP.
Glucose	From -10 minutes to 240 minutes.	Measured in serum.
C-peptide	From -10 minutes to 240 minutes.	Measured in serum.
Parathyroid hormone	From -10 minutes to 240 minutes.	PTH is a bone marker
Insulin	From -10 minutes to 240 minutes.	Measured in serum.
Sclerostin	From -10 minutes to 240 minutes.	Bone marker.
GLP-2	From -10 minutes to 240 minutes.	Intact GLP-2

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark