NCT00940966

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: CAMC Health System · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Elevated Triglycerides
• Systolic Hypertension
• Insulin Resistance
• Abdominal Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	standard ADA diet	standard ADA diet
DIETARY_SUPPLEMENT	energy restricted very-low carbohydrate diet	energy restricted very-low carbohydrate diet
DIETARY_SUPPLEMENT	low glycemic diet	restricted ketogenic diet

Timeline

• Start date: 2006-07-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-07-17
• Last updated: 2015-02-03

Locations

1 site across 1 country: United States