Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

University of Copenhagen

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: GIP; Other: GIP + GLP-2; Other: GLP-2; Other: Meal test; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05181150

CBC-SCI-21

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 5 patient groups, including a placebo group

Meal test

Experimental group

Treatment:

Other: Meal test

GIP, Glucose-dependent insulinotropic polypeptide

Experimental group

Treatment:

Other: GIP

GLP-2, Glucagon-like-peptide-2

Experimental group

Treatment:

Other: GLP-2

GIP + GLP-2

Experimental group

Treatment:

Other: GIP + GLP-2

Placebo (saline)

Placebo Comparator group

Treatment:

Other: Placebo