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

NCT00940966 | Completed

• 1 other identifier: 06-02-1776
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Triglycerides; Systolic Hypertension; Insulin Resistance; Abdominal Obesity

Keywords

ADA diet; low carbohydrate diet; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• weight loss

  1 year

Study Arms (3)

energy restricted very-low carbohydrate

EXPERIMENTAL

non-energy restricted ketogenic diet .

Dietary Supplement: energy restricted very-low carbohydrate diet

ADA diet

ACTIVE COMPARATOR

standard ADA diet

Dietary Supplement: standard ADA diet; Dietary Supplement: energy restricted very-low carbohydrate diet

low glycemic index

ACTIVE COMPARATOR

restricted ketogenic diet

Dietary Supplement: low glycemic diet

Interventions

standard ADA diet DIETARY_SUPPLEMENT

standard ADA diet

ADA diet

energy restricted very-low carbohydrate diet DIETARY_SUPPLEMENT

energy restricted very-low carbohydrate diet

ADA diet; energy restricted very-low carbohydrate

low glycemic diet DIETARY_SUPPLEMENT

restricted ketogenic diet

Also known as: ketogenic diet.

low glycemic index

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents and young adults ages 13-18 with a BMI\>95% for age or over 30 for young adults, with pre-existing metabolic syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Wvu Department of Pediatrics

Charleston, West Virginia, 25302, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Isolated Systolic Hypertension; Insulin Resistance; Obesity, Abdominal; Metabolic Syndrome

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Essential Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Steven Sondike, MD

  WVU Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: July 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

US (1)