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Can cutting carbs curb metabolic syndrome in teens?

NCT ID NCT00940966

Disease control Sponsor: CAMC Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This pilot study tests whether two low-carbohydrate diets can improve metabolic syndrome in adolescents aged 13-18 who are obese. Participants will follow either a very-low-carb diet, a restricted ketogenic diet, or the standard American Diabetes Association diet. The goal is to see which approach better improves weight loss and key diabetes risk factors like blood sugar and triglycerides.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-carbohydrate diets (very-low-carb and restricted ketogenic) compared with the standard ADA diet
What this could lead to
If effective, these diets could offer a drug-free way to manage metabolic syndrome in teens, potentially reducing future risk of type 2 diabetes and heart disease.
What could go wrong
This is a small pilot study, so results may not be conclusive. Low-carb diets can be hard to stick to, and long-term effects in teens are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Start date

Jul 2006

Finished

May 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome hypertensive disorder hypertriglyceridemia Insulin Resistance Isolated Systolic Hypertension metabolic syndrome X Obesity, Abdominal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abdominal obesity Elevated triglycerides Insulin resistance Systolic hypertension

Contacts and locations

Locations

  • Wvu Department of Pediatrics

    Charleston, West Virginia, 25302, United States

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