Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

NCT ID: NCT05181150

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2024-11-30

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.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Meal test

Group Type EXPERIMENTAL

Meal test

Intervention Type OTHER

Ingestion of an oral liquid meal (nutridrink), 200 mL.

GIP, Glucose-dependent insulinotropic polypeptide

Group Type EXPERIMENTAL

GIP

Intervention Type OTHER

Subcutaneous GIP injection.

GLP-2, Glucagon-like-peptide-2

Group Type EXPERIMENTAL

GLP-2

Intervention Type OTHER

Subcutaneous GLP-2 injection.

GIP + GLP-2

Group Type EXPERIMENTAL

GIP + GLP-2

Intervention Type OTHER

Subcutaneous GIP + GLP-2 injection.

Placebo (saline)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous saline injection.

Interventions

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Meal test

Ingestion of an oral liquid meal (nutridrink), 200 mL.

Intervention Type OTHER

GIP

Subcutaneous GIP injection.

Intervention Type OTHER

GLP-2

Subcutaneous GLP-2 injection.

Intervention Type OTHER

GIP + GLP-2

Subcutaneous GIP + GLP-2 injection.

Intervention Type OTHER

Placebo

Subcutaneous saline injection.

Intervention Type OTHER

Other Intervention Names

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Nutridrink

Eligibility Criteria

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Inclusion Criteria

* Spinal cord injury resulting in the need of a wheelchair
* BMI: 16-32 kg/m2


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Kirsa Skov-Jeppesen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette M Rosenkilde, Prof., MD

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Charlotte B Christiansen, PhD

Role: CONTACT

+45 22459802

Kirsa Skov-Jeppesen, PhD

Role: CONTACT

+45 26818619

Facility Contacts

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Sten Madsbad

Role: primary

Charlotte B Christiansen

Role: backup

Other Identifiers

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CBC-SCI-21

Identifier Type: -

Identifier Source: org_study_id

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