NCT00718874

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

July 18, 2008

Last Update Submit

November 21, 2019

Conditions

ObesityType 2 Diabetes

Keywords

obesity, puberty, diabetes,insulin dynamics

Outcome Measures

Primary Outcomes (1)

  • decreased insulin secretion

    25 weeks

Secondary Outcomes (1)

  • decreased markers of inflammation; decreased estradiol concentration

    25 weeks

Study Arms (2)

A, 1

EXPERIMENTAL

low-carbohydrate (42%)

Other: Dietary

A,2

EXPERIMENTAL

standard carbohydrate (55%) based on ADA recommendations

Other: Dietary

Interventions

DietaryOTHER

modification of macronutrient content

A, 1A,2

Eligibility Criteria

Age9 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • On medications known to affect metabolism prior disease diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Diet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Krista Casazza, PhD, RD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Krista R. Casazza PhD, RD/Assistant Professor, UAB

Study Record Dates

First Submitted

July 18, 2008

First Posted

July 21, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

US(1)