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NCT03867656 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03867656
Other study ID # KS-4-Diabetes-19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 26, 2019
Est. completion date June 26, 2020

Study information
Verified date November 2020
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 26, 2020
Est. primary completion date June 26, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• GLP-2
GLP-2 injection
• GIP
GIP injection
• Placebo
Placebo injection

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 CTX Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum. -10 minutes to 240 minutes
Primary P1NP Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum. -10 minutes to 240 minutes
Secondary PTH PTH measured in serum -10 minutes to 240 minutes
Secondary Sclerostin Bone marker. -10 min to 240 min.
Secondary Glucose Measured in serum -10 minutes to 240 minutes
Secondary Insulin Measured in serum -10 minutes to 240 minutes
Secondary C-peptide Measured in serum -10 minutes to 240 minutes
Secondary GIP Glucose-dependent insulinotropic polypeptide measured in plasma. -10 minutes to 240 minutes
Secondary GLP-2 Glucagon-like peptide 2 measured in plasma. -10 minutes to 240 minutes
Secondary Glucagon Glucagon measured in plasma -10 minutes to 240 minutes
Secondary Blood pressure Measured before blood sampling -10 minutes to 240 minutes
Secondary Heart rate Measured before blood sampling -10 minutes to 240 minutes
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