Effects of Gut Peptides on Bone Remodeling

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Other: Glucagon-Like Peptide-2 (GLP-2); Other: GLP-2+GIP; Other: Glucose-dependent insulinotropic polypeptide (GIP)

• Registration Number: NCT03574064
• Lead Sponsor: University of Copenhagen

Brief Summary

We will investigate effects of gut hormones on bone remodeling.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
N-terminal propeptide of type 1 procollagen (P1NP). At all time points and AUC(0-240 min).	-10 minutes to 600 minutes	P1NP is a marker of bone formation. Measured in serum.
C-terminal telopeptide (CTX). At all time points and AUC(0-240 min).	-10 minutes to 600 minutes	CTX is a marker of bone resorption. Measured in serum.

Secondary Outcome Measures

Name	Time	Method
Calcium	-10 minutes to 600 minutes	Measured in serum within 5 days.
Insulin	-10 minutes to 600 minutes	Measured in serum.
Glukagon-like peptide-2 (GLP-2)	-10 minutes to 600 minutes	Intact GLP-2. Measured in plasma.
C-peptide	-10 minutes to 600 minutes	Measured in serum.
PTH	-10 minutes to 600 minutes	Bone marker. Measured in serum.
Sclerostin	-10 minutes to 600 minutes	Bone marker.
PP	-10 minutes to 600 minutes	Measured in plasma.
Glucose	-10 minutes to 600 minutes	Measured in serum.
Glucose-dependent insulinotropic polypeptide (GIP)	-10 minutes to 600 minutes	Total and intact GIP. Measured in plasma.
Glukagon-like peptide-1 (GLP-1)	-10 minutes to 600 minutes	Measured in plasma.
Glucagon	-10 minutes to 600 minutes	Measured in plasma.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark