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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Abdominal Obesity; Systolic Hypertension; Elevated Triglycerides
• Intervention / Treatment: Dietary supplement: energy restricted very-low carbohydrate diet; Dietary supplement: standard ADA diet; Dietary supplement: low glycemic diet

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Charleston, West Virginia, United States, 25302
      • WVU Department of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: energy restricted very-low carbohydrate; non-energy restricted ketogenic diet .	Dietary supplement: energy restricted very-low carbohydrate diet; energy restricted very-low carbohydrate diet
Active Comparator: ADA diet; standard ADA diet	Dietary supplement: energy restricted very-low carbohydrate diet; energy restricted very-low carbohydrate diet; Dietary supplement: standard ADA diet; standard ADA diet
Active Comparator: low glycemic index; restricted ketogenic diet	Dietary supplement: low glycemic diet; restricted ketogenic diet; Other Names: ketogenic diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight loss	1 year

Collaborators and Investigators

• Sponsor: CAMC Health System
• Investigators: Principal Investigator: Steven Sondike, MD, WVU Department of Pediatrics

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2015
• Last Update Submitted That Met QC Criteria: February 2, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Metabolic syndrome; low carbohydrate diet; ADA diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Hyperinsulinism; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Obesity; Metabolic Syndrome; Insulin Resistance; Hypertriglyceridemia; Obesity, Abdominal
• Other Study ID Numbers: 06-02-1776