Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders

University of Copenhagen

Status: Enrolling

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

Treatments: Other: Meal test; Other: Placebo; Other: GIP + GLP-2

Study type: Interventional

Funder types: Other

Identifiers

NCT07254988

TK-23

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 3 patient groups, including a placebo group

Meal test

Experimental group

Description:

Oral liquid meal test

Treatment:

Other: Meal test

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

Experimental group

Description:

Subcutaneous co-injection of GIP and GLP-2

Treatment:

Other: GIP + GLP-2

Placebo

Placebo Comparator group

Description:

Subcutaneous injection of saline

Treatment:

Other: Placebo