Status:
COMPLETED
Mechanisms of Obesity and Its Metabolic Complications in Youth
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity, Childhood
Eligibility:
All Genders
15-21 years
Phase:
NA
Brief Summary
The overarching goal of this project is to determine whether the effect of gut microbiota on human metabolism might be mediated by short chain fatty acids (SCFA) and whether the SCFA might modulate li...
Detailed Description
This would be the first study determining the effect of SCFA synthesis on hepatic de novo lipogenesis and to assess whether and how isocaloric dietary changes (namely low carbohydrates) might modify t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Good general health,
- Taking no medication on a chronic basis
- Age 15 to 21 years,
- In puberty (girls and boys: Tanner stage III - V)
- BMI \>25th and \<85th for lean cohort; BMI \>95th for obese cohort
- Girls who begin menstruating must have a negative pregnancy test during the study.
- Exclusion criteria:
- Baseline creatinine \>1.0 mg
- Food allergies
- Pregnancy
- Presence of endocrinopathies (e.g. Cushing syndrome)
- Significant chronic illness.
Exclusion
Key Trial Info
Start Date :
August 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03454828
Start Date
August 18 2018
End Date
June 30 2024
Last Update
October 9 2025
Active Locations (1)
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1
Hospital Research Unit
New Haven, Connecticut, United States, 06520