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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by CAMC Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00940966
First received: July 15, 2009
Last updated: February 27, 2012
Last verified: February 2012
  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:


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: March 2012
Estimated Primary Completion Date: March 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:

  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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
ADA diet
low carbohydrate diet
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hypertension
Obesity, Abdominal
Syndrome
Hypertriglyceridemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Disease
Pathologic Processes
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 16, 2014