Status:
COMPLETED
Puberty Related Intervention to Improve Metabolic Outcomes (The PRIMO Study)
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Obesity
Eligibility:
FEMALE
7-11 years
Phase:
NA
Brief Summary
Puberty represents a critical period in terms of metabolic health. Racial differences in insulin dynamics, reproductive maturation, and the associated endocrine changes may affect a female's health la...
Detailed Description
This study will include 100 European and African American girls ages 7-11 years. Subjects must be non-diabetic and overweight (percentile BMI \>85th ). Screening First they will complete a telephone ...
Eligibility Criteria
Inclusion
- Self-identified as African American or European American
- Aged 7-11 AND Tanner stage \< 3
- Overweight (BMI percentile 85-97th)
- Not taking any medication known to affect body composition
- No prior diagnosis of chronic condition
Exclusion
- Illness that precludes study participation
- Prescribed medication known to affect body composition
- Not of EA or AA racial/ethnic group
- Obese (BMI% \> 97th) or normal weight (BMI% \< 85th)
- Reproductively mature as define by Tanner stage \> 3
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01410643
Start Date
March 1 2011
End Date
March 1 2015
Last Update
November 25 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UAB
Birmingham, Alabama, United States, 35294