Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07254988

Enrollment

Registered

2025-11-28

Start date

2023-03-24

Completion date

2026-12-31

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

OTHERMeal test

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

OTHERGIP + GLP-2

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

OTHERPlacebo

Subcutaneous saline injection (2 mL isotonic saline).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
CTX	-10 to 240 minutes	Bone resorption measured as carboxy-terminal telopeptide of type I collagen (CTX)

Secondary

Measure	Time frame	Description
PTH	-10 to 240 minutes	Parathyroid hormone (PTH) measured in plasma
Glucose	-10 to 240 minutes	Blood glucose measured in plasma
GIP	-10 to 240 minutes	Glucose-dependent insulinotropic polypeptide (GIP) measured in plasma
P1NP	-10 to 240 minutes	Bone formation measured as procollagen type I N-terminal propeptide (P1NP)
Blood pressure	-10 to 240 minutes	Measured before blood sampling
Heart rate	-10 to 240 minutes	Measured before blood sampling
GLP-2	-10 to 240 minutes	Glucagon-like-peptide 2 (GLP-2) measured in plasma

Countries

Denmark

Contacts

Primary ContactBolette Hartmann

bhartmann@sund.ku.dk+45 23264411

Backup ContactCharlotte Bayer Christiansen

cbchristiansen@sund.ku.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026