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

This study has been completed.
Thrasher Research Fund
Information provided by (Responsible Party):
Krista Casazza, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
First received: July 18, 2008
Last updated: April 18, 2012
Last verified: April 2012
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)

Condition Intervention
Type 2 Diabetes
Other: Dietary

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • decreased insulin secretion [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • decreased markers of inflammation; decreased estradiol concentration [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, 1
low-carbohydrate (42%)
Other: Dietary
modification of macronutrient content
Experimental: A,2
standard carbohydrate (55%) based on ADA recommendations
Other: Dietary
modification of macronutrient content


Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • On medications known to affect metabolism prior disease diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718874

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Thrasher Research Fund
Principal Investigator: Krista Casazza, PhD, RD University of Alabama at Birmingham
  More Information

Responsible Party: Krista Casazza, Krista R. Casazza PhD, RD/Assistant Professor, UAB, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00718874     History of Changes
Other Study ID Numbers: F080605012 
Study First Received: July 18, 2008
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
obesity, puberty, diabetes,insulin dynamics

ClinicalTrials.gov processed this record on May 25, 2016