Effects of Gut Peptides on Bone Remodeling. KS-4-Diabetes-19

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Placebo; Other: GLP-2; Other: GIP

• Registration Number: NCT03867656
• Lead Sponsor: University of Copenhagen

Brief Summary

Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-08
• Primary Completion: 2020-06-26
• Study Completion: 2020-06-26
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

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

Inclusion Criteria

• Male
• Age 25 to 70 years old.
• Type 2 diabetes.
• In Metformin or sulfonylureas

Exclusion Criteria

• Treatment with other antidiabetics
• Osteopososis or gastrointestinal disease
• Smoking
• Long term steroid treatment
• Weight change more than 3 kg within the last 3 months.
• Overweight or intestinal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline
GLP-2	GLP-2	Glucagon-like peptide 2
GIP	GIP	Glucose-dependent insulinotropic polypeptide

Primary Outcome Measures

Name	Time	Method
CTX	-10 minutes to 240 minutes	Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.
P1NP	-10 minutes to 240 minutes	Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.

Secondary Outcome Measures

Name	Time	Method
PTH	-10 minutes to 240 minutes	PTH measured in serum
Sclerostin	-10 min to 240 min.	Bone marker.
Glucose	-10 minutes to 240 minutes	Measured in serum
C-peptide	-10 minutes to 240 minutes	Measured in serum
Insulin	-10 minutes to 240 minutes	Measured in serum
GIP	-10 minutes to 240 minutes	Glucose-dependent insulinotropic polypeptide measured in plasma.
GLP-2	-10 minutes to 240 minutes	Glucagon-like peptide 2 measured in plasma.
Glucagon	-10 minutes to 240 minutes	Glucagon measured in plasma
Blood pressure	-10 minutes to 240 minutes	Measured before blood sampling
Heart rate	-10 minutes to 240 minutes	Measured before blood sampling

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark