Status:
COMPLETED
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Lead Sponsor:
CAMC Health System
Conditions:
Elevated Triglycerides
Systolic Hypertension
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief 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 hemogl...
Detailed Description
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 hemogl...
Eligibility Criteria
Inclusion
- Adolescents and young adults ages 13-18 with a BMI\>95% for age or over 30 for young adults, with pre-existing metabolic syndrome
Exclusion
- Subjects on any chronic medication other than antihistamines, asthma medications, oral contraceptives or diabetes medications, smoke more than 5 cigarettes/day, suffer from alcoholism or drug abuse or have any significant abnormality not associated with metabolic syndrome on screening labs will be excluded from randomization.
- Subjects currently taking Byetta will be excluded from the study, as a side effect of the drug is weight loss.
- Subjects with familial hypercholesteremia may be excluded if the investigator considers the history to be severe. The data collected from subjects with a HBA1C greater than 12.5 will be analyzed in a separate group, although they will still be randomized to one of the three treatment groups. This is due to the fact that past experience has shown that these individuals run a high risk of being non-compliant with medication use, diet, and exercise plans. Results from this group will be reported separately.
- Subjects who are pregnant or those desiring pregnancy will be excluded, as the safety of this intervention in pregnancy has not been established.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00940966
Start Date
July 1 2006
End Date
May 1 2012
Last Update
February 3 2015
Active Locations (1)
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1
Wvu Department of Pediatrics
Charleston, West Virginia, United States, 25302