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.

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

Inclusion Criteria:

- 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 Criteria:

- 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.