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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940966
• Other study ID #: 06-02-1776
• Status: Completed
• Phase: N/A
• First received: July 15, 2009
• Last updated: February 2, 2015
• Start date: July 2006
• Est. completion date: May 2012

Study information

• Verified date: February 2015
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity
• Elevated Triglycerides
• Hypertension
• Hypertriglyceridemia
• Insulin Resistance
• Metabolic Syndrome X
• Obesity, Abdominal
• Systolic Hypertension

Intervention

Dietary Supplement:
• standard ADA diet
standard ADA diet
• energy restricted very-low carbohydrate diet
energy restricted very-low carbohydrate diet
• low glycemic diet
restricted ketogenic diet

Locations

Country	Name	City	State
United States	Wvu Department of Pediatrics	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		1 year	No