A Specialized Diet for the Unique Metabolic Characteristics of Peripubertal African American Girls

Not Applicable

Completed

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Other: Dietary

• Registration Number: NCT00718874
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

A diet (42% carbohydrate) specialized to the unique metabolic characteristics of peripubertal African AMerican girls (hyperinsulinemic, low insulin sensitive) will be more effective in maintaining glucose and insulin homeostasis compared to a standard diet (55% carbohydrate)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• African American girls aged 9-14,
• Overweight < 90th percentile

Exclusion Criteria

• On medications known to affect metabolism prior disease diagnosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A, 1	Dietary	low-carbohydrate (42%)
A,2	Dietary	standard carbohydrate (55%) based on ADA recommendations

Primary Outcome Measures

Name	Time	Method
decreased insulin secretion	25 weeks

Secondary Outcome Measures

Name	Time	Method
decreased markers of inflammation; decreased estradiol concentration	25 weeks

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States