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

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Krista Casazza, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00718874
First received: July 18, 2008
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Obesity
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

Resource links provided by NLM:

U.S. FDA Resources

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

  Eligibility

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

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

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

No publications provided

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013