Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Meal test
* Other: GIP
* Other: GLP-2
* Other: GIP + GLP-2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meal test<br> | Other: Meal test<br>* Ingestion of an oral liquid meal (nutridrink), 200 mL.<br>* Other names: Nutridrink;|
| Experimental: GIP, Glucose-dependent insulinotropic polypeptide<br> | Other: GIP<br>* Subcutaneous GIP injection.<br>|
| Experimental: GLP-2, Glucagon-like-peptide-2<br> | Other: GLP-2<br>* Subcutaneous GLP-2 injection.<br>|
| Experimental: GIP + GLP-2<br> | Other: GIP + GLP-2<br>* Subcutaneous GIP + GLP-2 injection.<br>|
| Placebo Comparator: Placebo (saline)<br> | Other: Placebo<br>* Subcutaneous saline injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTX | Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum. | -10 to 240 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, GIP, GLP-2, CTX, P1NP, Bone resorption, Bone formation, Bone turnover, Bone remodeling