ClinicalTrials.gg
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

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 150 studies in Hypertriglyceridemia with a site in United States — 10 open to participants now, 16 under way, 4 of them phase 3. Hypertriglyceridemia · United States.

Enrollment
86th of 145
40 · median 52
Started
2006
with 7 others
No phase
36 of 150
2 open now
Registered
41st of 150
by date

Among the 150 studies in Hypertriglyceridemia with a site in United States, this one is the 86th largest by enrollment of the 145 interventional ones that give a count, is one of 8 that started in 2006, is one of 36 with no phase, and was the 41st registered.

Hypertriglyceridemia

324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.

Browse Hypertriglyceridemia studies →

Open to participants now

10 of the 150 studies in Hypertriglyceridemia with a site in United States are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 22 Hypertriglyceridemia studies recruiting now, 9 (41%) set no upper age limit and 12 (55%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 12 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 150 studies in Hypertriglyceridemia with a site in United States, or all of them as a file.
02

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
03

Conditions studied

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

Keywords

  • ADA diet
  • low carbohydrate diet
  • Metabolic syndrome
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescents and young adults ages 13-18 with a >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 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

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.

06

What researchers measure

Primary outcomes

  1. weight loss

    Time frame: 1 year

07

Study locations

1 site
  • Wvu Department of Pediatrics
    Charleston, West Virginia 25302, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2006, a primary completion of May 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2009
First posted
Jul 17, 2009
Start
Jul 2006
Primary completionActual
May 2012
CompletionActual
May 2012
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion