NCT05991609|Active Not Recruiting
Extreme Morphology and Metabolic Health
Establishing the Metabolic and Nutritional Requirements of Individuals With Extreme Body Morphology
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Establishing the Metabolic and Nutritional Requirements of Individuals With Extreme Body Morphology
Sponsor study identifier
observational
102
1 country
1
Study Start
June 17, 2023
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 28, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 28, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 17, 2023
Actual (reported)July 20, 2023
Actual (reported)August 14, 2023
Actual (reported)September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 28, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Height
Baseline
Body mass
Baseline
Change in body mass over 14 days of free-living monitoring
14 days
Any individual with a form of skeletal dysplasia, or extremely small or large body size.
Individuals with extreme body size or proportions.
University of Bath
Bath, BA27AY, United Kingdom
Buffy coat layer from blood
James A Betts, PhD
University of Bath
First Submitted
July 20, 2023
First Posted
August 14, 2023
Study Start
June 17, 2023
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 28, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 10, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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