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
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
- Elevated Triglycerides
- Systolic Hypertension
- Insulin Resistance
- Abdominal Obesity
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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