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Completed

NCT Number: NCT00718874

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

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)

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

9 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • On medications known to affect metabolism prior disease diagnosis

Treatment and study plan

Dietary

Other

modification of macronutrient content

Primary outcomes

  1. decreased insulin secretion

    Time frame: 25 weeks

Secondary outcomes

  1. decreased markers of inflammation; decreased estradiol concentration

    Time frame: 25 weeks

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

Dietary Intervention to Improve Insulin Dynamics During the Pubertal Transition

Acronym: PRIMO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 21, 2008
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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