Back to resultsA Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Primary Purpose
Elevated Triglycerides, Systolic Hypertension, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard ADA diet
energy restricted very-low carbohydrate diet
low glycemic diet
Sponsored by
About this trial
This is an interventional treatment trial for Elevated Triglycerides focused on measuring ADA diet, low carbohydrate diet, Metabolic syndrome
Eligibility 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.
Sites / Locations
- Wvu Department of Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
energy restricted very-low carbohydrate
ADA diet
low glycemic index
Arm Description
non-energy restricted ketogenic diet .
standard ADA diet
restricted ketogenic diet
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00940966
Brief Title
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Official Title
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CAMC Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elevated Triglycerides, Systolic Hypertension, Insulin Resistance, Abdominal Obesity
Keywords
ADA diet, low carbohydrate diet, Metabolic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
energy restricted very-low carbohydrate
Arm Type
Experimental
Arm Description
non-energy restricted ketogenic diet .
Arm Title
ADA diet
Arm Type
Active Comparator
Arm Description
standard ADA diet
Arm Title
low glycemic index
Arm Type
Active Comparator
Arm Description
restricted ketogenic diet
Intervention Type
Dietary Supplement
Intervention Name(s)
standard ADA diet
Intervention Description
standard ADA diet
Intervention Type
Dietary Supplement
Intervention Name(s)
energy restricted very-low carbohydrate diet
Intervention Description
energy restricted very-low carbohydrate diet
Intervention Type
Dietary Supplement
Intervention Name(s)
low glycemic diet
Other Intervention Name(s)
ketogenic diet.
Intervention Description
restricted ketogenic diet
Primary Outcome Measure Information:
Title
weight loss
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Sondike, MD
Organizational Affiliation
WVU Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wvu Department of Pediatrics
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
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