Extreme Morphology and Metabolic Health

NCT05991609 | Active Not Recruiting

• 1 other identifier: 321662
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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 risks such as heart disease. By better understanding how body size could change how the body processes food, or how being bigger or smaller may influence eating habits, healthy living guidelines to tackle issues such as obesity and overweight in these populations can be improved. With help from expertise in the psychology field, this research will also investigate whether the mental health of these individuals has been affected by their size. On the whole, this study will involve one 24-hour visit to a research laboratory at the University of Bath, followed by a 2-week monitoring period to capture 'normal' physical activity and eating routines.

Conditions

Skeletal Dysplasia

Keywords

Morphology; Skeletal dysplasia; Metabolism

Outcome Measures

Primary Outcomes (1)

• Glucose incremental area under the curve during the oral glucose tolerance test

  Difference in blood glucose incremental area under the curve between individuals with skeletal dysplasia, and extremely small and large body size.

  3 hours

Secondary Outcomes (21)

• Fasted blood glucose concentration

  Baseline

• Fasted blood insulin concentration

  Baseline

• Insulin response to oral glucose tolerance test

  3 hours

• C-Peptide response to oral glucose tolerance test

  3 hours

• Regulatory hormone response to oral glucose tolerance test

  3 hours

Other Outcomes (34)

• Height

  Baseline

• Body mass

  Baseline

• Change in body mass over 14 days of free-living monitoring

  14 days

Study Arms (1)

Individuals with extreme body size

Any individual with a form of skeletal dysplasia, or extremely small or large body size.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with extreme body size or proportions.

You may qualify if:

• 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).

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• University of Bath: lead
• University of Bristol: collaborator

Study Sites (1)

University of Bath

Bath, BA27AY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coat layer from blood

MeSH Terms

Conditions

Mucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• James A Betts, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 14, 2023
• Study Start: June 17, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 28, 2035
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)