Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Other: GIP; Other: GLP-2; Other: Placebo; Other: Meal test; Other: GIP + GLP-2

• Registration Number: NCT05181150
• Lead Sponsor: University of Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-16
• Study First Submitted: 2021-12-18
• Study First Submitted QC: 2021-12-18
• Study First Posted: 2022-01-06
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIP, Glucose-dependent insulinotropic polypeptide	GIP	-
GLP-2, Glucagon-like-peptide-2	GLP-2	-
Placebo (saline)	Placebo	-
Meal test	Meal test	-
GIP + GLP-2	GIP + GLP-2	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark