Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders

NCT ID: NCT07254988

Last Updated: 2025-11-28

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

RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Muscular Atrophy (SMA) Cerebral Palsy (CP) Duchenne Muscular Dystrophy (DMD)

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

Oral liquid meal test

Group Type EXPERIMENTAL

Meal test

Intervention Type OTHER

Ingestion of an oral liquid meal (nutridrink), 3.3 mL/kg body weight.

Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2)

Subcutaneous co-injection of GIP and GLP-2

Group Type EXPERIMENTAL

GIP + GLP-2

Intervention Type OTHER

Subcutaneous GIP + GLP-2 injection (1 mL containing 100 microgram GIP + 1 mL containing 400 microgram GLP-2).

Placebo

Subcutaneous injection of saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subcutaneous saline injection (2 mL isotonic saline).

Interventions

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Meal test

Ingestion of an oral liquid meal (nutridrink), 3.3 mL/kg body weight.

Intervention Type OTHER

GIP + GLP-2

Subcutaneous GIP + GLP-2 injection (1 mL containing 100 microgram GIP + 1 mL containing 400 microgram GLP-2).

Intervention Type OTHER

Placebo

Subcutaneous saline injection (2 mL isotonic saline).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Bolette Hartmann

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette Marie Rosenkilde

Role: STUDY_DIRECTOR

University of Copenhagen

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Bolette Hartmann

Role: CONTACT

Phone: +45 23264411

Email: [email protected]

Charlotte Bayer Christiansen

Role: CONTACT

Email: [email protected]

Facility Contacts

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Bolette Hartmann

Role: primary

Other Identifiers

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TK-23

Identifier Type: -

Identifier Source: org_study_id