Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury

May 9, 2023 updated by: Kirsa Skov-Jeppesen, University of Copenhagen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kirsa Skov-Jeppesen, PhD
  • Phone Number: +45 26818619
  • Email: kirsa@sund.ku.dk

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Hvidovre University Hospital

Investigators

  • Study Director: Mette M Rosenkilde, Prof., MD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

December 18, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBC-SCI-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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