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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 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. 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

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

Conditions
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Elevated Triglycerides, Systolic Hypertension, Insulin Resistance, Abdominal Obesity

Intervention / Treatment
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* Dietary Supplement: standard ADA diet
* Dietary Supplement: energy restricted very-low carbohydrate diet
* Dietary Supplement: low glycemic diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: energy restricted very-low carbohydrate<br>non-energy restricted ketogenic diet . | Dietary Supplement: energy restricted very-low carbohydrate diet<br>* energy restricted very-low carbohydrate diet<br>|
| Active Comparator: ADA diet<br>standard ADA diet | Dietary Supplement: standard ADA diet<br>* standard ADA diet<br>Dietary Supplement: energy restricted very-low carbohydrate diet<br>* energy restricted very-low carbohydrate diet<br>|
| Active Comparator: low glycemic index<br>restricted ketogenic diet | Dietary Supplement: low glycemic diet<br>* restricted ketogenic diet<br>* Other names: ketogenic diet.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADA diet, low carbohydrate diet, Metabolic syndrome