Status:

ACTIVE_NOT_RECRUITING

Extreme Morphology and Metabolic Health

Lead Sponsor:

University of Bath

Collaborating Sponsors:

University of Bristol

Conditions:

Skeletal Dysplasia

Eligibility:

All Genders

16+ years

Brief Summary

Researchers at the University of Bath are investigating the metabolism of individuals with extreme body size, including those with skeletal dysplasia (commonly known as dwarfism), to manage health ris...

Detailed Description

After signing informed consent to take part in the study, participants will be asked to complete a health entry criteria questionnaire, including a physical activity readiness questionnaire and Eating...

Eligibility Criteria

Inclusion

  • Aged 16 years or over
  • Any diagnosed form of skeletal dysplasia (i.e., extreme proportionate or disproportionate short stature)
  • Individuals without skeletal dysplasia but presenting with extreme body morphology, defined as: individuals with extreme large body morphology (males \>75 kg fat-free mass and females \>57.25 kg fat-free mass), or males and females with extreme small body morphology (\<47.4 kg fat-free mass).

Exclusion

  • Any reported condition, behaviour or reported use of substances which may pose undue personal risk to the participant or introduce bias into the study, except for any which are ubiquitous in society and so would be equally distributed between groups and/or therefore relevant to generalisation (e.g., statins, caffeine, GLP-1 agonists).
  • Females who are pregnant or lactating
  • Individuals with a diagnosed history of eating disorders (e.g., anorexia)
  • Individuals with known bleeding disorders (exclusion for biopsies only)
  • Individuals with known allergy or intolerance to lidocaine
  • Inability to read or speak English, or otherwise to consent to procedures
  • Individuals who are not weight stable (i.e., \>3 kg change in body mass in past 3 months)

Key Trial Info

Start Date :

June 17 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 28 2035

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT05991609

Start Date

June 17 2023

End Date

September 28 2035

Last Update

February 10 2025

Active Locations (1)

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1

University of Bath

Bath, United Kingdom, BA27AY