Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders

April 13, 2026 updated by: Bolette Hartmann, University of Copenhagen
Both GIP and GLP-2 reduce bone resorption (measured as CTX) in healthy adult individuals. In this study, we will investigate whether GIP and GLP-2 reduce CTX in children with spinal muscular atrophy, duchenne muscular dystrophy, or cerebral palsy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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 Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Diagnosis with Cerebral palsy (CP), Duchenne muscular dystrophy (DMD) or Spinal muscular atrophy (SMA) resulting in the need of a wheelchair

Exclusion Criteria:

  • Use of anti-resorptive medication
  • Confounding illnesses
  • Pregnancy
  • Allergy towards the components given on the test days
  • Hgb<6.5 mmol/L

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
Experimental: Meal test
Oral liquid meal test
Other: Meal test
Ingestion of an oral liquid meal (nutridrink), 3.3 mL/kg body weight.
Experimental: Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2)
Subcutaneous co-injection of GIP and GLP-2
Other: GIP + GLP-2
Subcutaneous GIP + GLP-2 injection (1 mL containing 100 microgram GIP + 1 mL containing 400 microgram GLP-2).
Placebo Comparator: Placebo
Subcutaneous injection of saline
Other: Placebo
Subcutaneous saline injection (2 mL isotonic saline).

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 carboxy-terminal telopeptide of type I collagen (CTX)
-10 to 240 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
P1NP
Time Frame: -10 to 240 minutes
Bone formation measured as procollagen type I N-terminal propeptide (P1NP)
-10 to 240 minutes
PTH
Time Frame: -10 to 240 minutes
Parathyroid hormone (PTH) measured in plasma
-10 to 240 minutes
Glucose
Time Frame: -10 to 240 minutes
Blood glucose measured in plasma
-10 to 240 minutes
GIP
Time Frame: -10 to 240 minutes
Glucose-dependent insulinotropic polypeptide (GIP) measured in plasma
-10 to 240 minutes
GLP-2
Time Frame: -10 to 240 minutes
Glucagon-like-peptide 2 (GLP-2) measured in plasma
-10 to 240 minutes

Collaborators and Investigators

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

Sponsor

University of Copenhagen

Investigators

  • Study Director: Mette Marie Rosenkilde, 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)

March 24, 2023

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TK-23

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.

Clinical Trials on Cerebral Palsy (CP)

Clinical Trials on Meal test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe