Elevated TriglyceridesNCT00940966
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
A study testing standard ADA diet, energy restricted very-low carbohydrate diet and low glycemic diet in people with Elevated Triglycerides and Systolic Hypertension, run by CAMC Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Elevated Triglycerides, Systolic Hypertension, Insulin Resistance
- What is being tested?
- standard ADA diet, energy restricted very-low carbohydrate diet and low glycemic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents and young adults ages 13-18 with a BMI>95% for age or over 30 for young adults, with pre-existing metabolic syndrome
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wvu Department of Pediatrics
Charleston, West Virginia, 25302
About this study
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:
- 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
- Being tested
- standard ADA diet, energy restricted very-low carbohydrate diet, low glycemic diet
- Keywords
- ADA diet, low carbohydrate diet, Metabolic syndrome
- Medical subject headings
- Hypertriglyceridemia, Isolated Systolic Hypertension, Insulin Resistance, Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard ADA dietDietary supplement
standard ADA diet
energy restricted very-low carbohydrate dietDietary supplement
energy restricted very-low carbohydrate diet
low glycemic dietDietary supplement
Also called ketogenic diet.
restricted ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| energy restricted very-low carbohydrate | Experimental | non-energy restricted ketogenic diet . Receives: Dietary Supplement: energy restricted very-low carbohydrate diet |
| ADA diet | Active comparator | standard ADA diet Receives: Dietary Supplement: standard ADA diet; Dietary Supplement: energy restricted very-low carbohydrate diet |
| low glycemic index | Active comparator | restricted ketogenic diet Receives: Dietary Supplement: low glycemic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJul 2006
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated TriglyceridesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Sondike, MD, Principal investigator, WVU Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940966
- Sponsor's protocol ID
- 06-02-1776
- Status last verified
- Feb 2015
- First submitted
- 15 Jul 2009
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00940966
- Acronym / sponsor ID
- 06-02-1776
- Keywords
- ADA diet, low carbohydrate diet, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| energy restricted very-low carbohydrate | Experimental | Dietary Supplement: energy restricted very-low carbohydrate dietnon-energy restricted ketogenic diet . |
| ADA diet | Active comparator | Dietary Supplement: standard ADA diet, Dietary Supplement: energy restricted very-low carbohydrate dietstandard ADA diet |
| low glycemic index | Active comparator | Dietary Supplement: low glycemic dietrestricted ketogenic diet |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents and young adults ages 13-18 with a BMI>95% for age or over 30 for young adults, with pre-existing metabolic syndrome
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard ADA dietstandard ADA diet | Dietary supplement | ADA diet |
| energy restricted very-low carbohydrate dietenergy restricted very-low carbohydrate diet | Dietary supplement | ADA diet, energy restricted very-low carbohydrate |
| low glycemic dietAlso: ketogenic diet.restricted ketogenic diet | Dietary supplement | low glycemic index |
Primary outcome
weight loss
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Sondike, MD principal investigator
WVU Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard ADA diet, energy restricted very-low carbohydrate diet and low glycemic diet in people with Elevated Triglycerides and Systolic Hypertension, run by CAMC Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.