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

Sponsor:	CAMC Health System
Information provided by:	CAMC Health System
ClinicalTrials.gov Identifier:	NCT00940966

Purpose

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.

Condition	Intervention
Elevated Triglycerides Systolic Hypertension Insulin Resistance Abdominal Obesity	Dietary Supplement: standard ADA diet Dietary Supplement: energy restricted very-low carbohydrate diet Dietary Supplement: low glycemic diet

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines High Blood Pressure Metabolic Syndrome Obesity Triglycerides

U.S. FDA Resources

Further study details as provided by CAMC Health System:

Primary Outcome Measures:

weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2006
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: standard ADA diet standard ADA diet Other Name: standard ADA diet Dietary Supplement: energy restricted very-low carbohydrate diet energy restricted very-low carbohydrate diet
Active Comparator: low glycemic index restricted ketogenic diet	Dietary Supplement: low glycemic diet restricted ketogenic diet Other Name: ketogenic 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:

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
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.
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

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940966

Locations

United States, West Virginia
Wvu Department of Pediatrics	Recruiting
Charleston, West Virginia, United States, 25302
Contact: Maher kali 304-388-9909 maher.kali@camc.org
Principal Investigator: steven sondike, MD

Sponsors and Collaborators

CAMC Health System

Investigators

Principal Investigator:

Steven Sondike, MD

WVU Department of Pediatrics

More Information

No publications provided

Responsible Party:	Steven sondike MD, WVU department of pediatrics
ClinicalTrials.gov Identifier:	NCT00940966 History of Changes
Other Study ID Numbers:	06-02-1776
Study First Received:	July 15, 2009
Last Updated:	July 14, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by CAMC Health System:

ADA diet
low carbohydrate diet
Metabolic syndrome

Additional relevant MeSH terms:

Hypertension
Hypertriglyceridemia
Insulin Resistance
Obesity
Obesity, Abdominal
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias

Lipid Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012