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CompletedNCT00940966Updated Aug 21, 2026

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

An interventional study of standard ADA diet and energy restricted very-low carbohydrate diet in Elevated Triglycerides, Systolic Hypertension and Insulin Resistance, sponsored by CAMC Health System. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by CAMC Health System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Elevated Triglycerides
  • Systolic Hypertension
  • Insulin Resistance
  • Abdominal Obesity

Keywords

  • ADA diet
  • low carbohydrate diet
  • Metabolic syndrome
03

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
40 participants (actual)

Study arms

  • Experimental
    energy restricted very-low carbohydrate

    non-energy restricted ketogenic diet .

    Dietary Supplement: energy restricted very-low carbohydrate diet

  • Active comparator
    ADA diet

    standard ADA diet

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

  • Active comparator
    low glycemic index

    restricted ketogenic diet

    Dietary Supplement: low glycemic diet

Interventions

  • Dietary supplementstandard ADA diet

    standard ADA diet

  • Dietary supplementenergy restricted very-low carbohydrate diet

    energy restricted very-low carbohydrate diet

  • Dietary supplementlow glycemic diet

    restricted ketogenic diet

    Also known as: ketogenic diet.

05

What researchers measure

Primary outcomes

  1. weight loss

    Time frame: 1 year

06

Study locations

1 site
  • Wvu Department of Pediatrics
    Charleston, West Virginia 25302, United States
07

Registry details

Key details

Study ID
NCT00940966
Lead sponsor
CAMC Health System
Responsible party
Sponsor
First posted
Jul 17, 2009
Start date
Jul 2006
Primary completion
May 2012
Completion
May 2012
Last update
Aug 21, 2026

Study contacts

Steven Sondike, MD
principal investigator · WVU Department of Pediatrics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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