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NCT05181150 Clinical Trial

Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:
Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05181150
Other study ID # CBC-SCI-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 16, 2021
Est. completion date November 2024

Study information
Verified date May 2023
Source University of Copenhagen
Contact Charlotte B Christiansen, PhD
Phone +45 22459802
Email cbchristiansen@sund.ku.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria (Individuals with spinal cord injury): - Spinal cord injury resulting in the need of a wheelchair - BMI: 16-32 kg/m2 Inclusion Criteria (Healthy controls): - Intact spinal cord - Matched on gender, age and BMI to the group with spinal cord injury Exclusion Criteria: - Treatment with antidiabetics - Treatment with anti-resorptive agents - 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:
• Meal test
Ingestion of an oral liquid meal (nutridrink), 200 mL.
• GIP
Subcutaneous GIP injection.
• GLP-2
Subcutaneous GLP-2 injection.
• GIP + GLP-2
Subcutaneous GIP + GLP-2 injection.
• Placebo
Subcutaneous saline 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 to 240 minutes
Secondary P1NP Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum. -10 to 240 minutes
Secondary PTH PTH measured in serum PTH measured in serum -10 to 240 minutes
Secondary Sclerostin Bone marker -10 to 240 minutes
Secondary Glucose Measured in serum -10 to 240 minutes
Secondary Insulin Measured in serum -10 to 240 minutes
Secondary C-peptide Measured in serum -10 to 240 minutes
Secondary GIP Glucose-dependent insulinotropic polypeptide measured in plasma -10 to 240 minutes
Secondary GLP-2 Glucagon-like peptide 2 measured in plasma. -10 to 240 minutes
Secondary Glucagon Glucagon measured in plasma -10 to 240 minutes
Secondary Blood pressure Measured before blood sampling -10 to 240 minutes
Secondary Heart rate Measured before blood sampling -10 to 240 minutes
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