A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome - NCT00940966-25302 (Clinical Trial 302354)
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| City: |
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CHARLESTON |
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State:
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WV |
| Zip Code: |
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25302 |
| Conditions: |
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Elevated Triglycerides - Systolic Hypertension - Insulin Resistance - Abdominal Obesity |
| Purpose: |
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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.
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| Study 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.
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 |
| 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. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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