A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome

NCT00940966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-02-03

No results posted yet for this study

Summary

The purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the American Diabetes Associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease.

Conditions

Interventions

DIETARY_SUPPLEMENT

standard ADA diet

standard ADA diet

DIETARY_SUPPLEMENT

energy restricted very-low carbohydrate diet

energy restricted very-low carbohydrate diet

DIETARY_SUPPLEMENT

low glycemic diet

restricted ketogenic diet

Sponsors & Collaborators

  • CAMC Health System

    lead OTHER

Principal Investigators

  • Steven Sondike, MD · WVU Department of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00940966 on ClinicalTrials.gov