Insulin Resistance Clinical Trial
Official title:
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
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.
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.
We plan to address the following issues:
1. To test the hypothesis that a controlled carbohydrate nutrition plan will be superior
to the standard ADA diet in controlling blood sugar (as measured by glycosylated
hemoglobin [HbA1C]), decreasing cardiovascular risk factors (Serum Lipid Levels, Blood
Pressure) and decreasing weight in adolescents with metabolic syndrome
2. To evaluate the tolerability of a non-energy restricted very-low carbohydrate diet in
these patients as measured by the SF-10 for Children, the Brief Symptom Inventory (BSI)
and a scaled questionnaire regarding side effects.
3. To compare two different maintenance programs in the group who receive the non- energy
restricted very-low carbohydrate diet and compare each group to the group
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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