Abdominal Obesity, Elevated Triglycerides, Insulin Resistance, Systolic Hypertension
Conditions
Keywords
ADA diet, low carbohydrate diet, Metabolic syndrome
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 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
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
Interventions
DIETARY_SUPPLEMENTstandard ADA diet
standard ADA diet
DIETARY_SUPPLEMENTenergy restricted very-low carbohydrate diet
energy restricted very-low carbohydrate diet
DIETARY_SUPPLEMENTlow glycemic diet
restricted ketogenic diet
Sponsors
CAMC Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight loss | 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven Sondike, MD
WVU Department of Pediatrics
Outcome results
None listed