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Can a Two-Week insulin vacation help young diabetics?

NCT ID NCT00445627

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 7 times

Summary

This study looks at how type 2 diabetes affects young people aged 12 to 25. Researchers want to see if giving the pancreas a 2-week rest with insulin shots can improve its ability to make insulin. Participants take metformin, follow a diet, and some also get insulin. The study also compares them to healthy teens to understand differences in body fat, heart health, and emotional well-being.

What this could mean

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

Active substance
Metformin, Insulin, Nutrition counseling, Exercise counseling
What this could lead to
If successful, this study could reveal whether giving beta cells a short rest with insulin improves their function in young people with type 2 diabetes, pointing toward better early treatments.
What could go wrong
This is an early, small observational and interventional study with only 82 participants, so results may not apply broadly. The 2-week insulin rest may not lead to lasting benefits.

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.

Participants

82 people

The number who actually took part.

Started

Jun 2007

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Who is studied

Children and young adults ages 8 to 25 years with type 2 diabetes will be studied in a cross-sectional and longitudinal manner.

Ages

8 to 25 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.

* DIABETIC SUBJECTS: INCLUSION CRITERIA: 1. Type 2 diabetes mellitus as defined by: 1. Fasting blood glucose greater than or equal to 126 mg/dL OR postprandial blood sugar greater than or equal to 200 mg/dL (either during OGTT at NIH or as previously documented on outside medical record). 2. Since subjects may already have been started on treatment with hypoglycemic agents at the time of enrollment, they may have blood glucose levels in the impaired glucose tolerance range (fasting glucose 100-125 mg/dL and postprandial 140-199 mg/dL). This is a sign of adequately controlled diabetes, rather than an incorrect diagnosis of diabetes. Therefore, prior documentation (on outside medical records) of blood glucose values documenting diabetes will be acceptable if the subject has impaired glucose tolerance rather than overt diabetes according to screening results at NIH. 3. Absence of insulin autoantibodies (in insulin na(SqrRoot) ve patients only) Or 2. Clinical diagnosis of type 1 diabetes mellitus (for Pilot Study only) And 3. Age 8-25 years at enrollment EXCLUSION CRITERIA: 1. Normal OGTT at NIH (fasting blood glucose \< 100 mg/dL AND 2 hour blood glucose \< 140 mg/dL) 2. Significant comorbidity that, in the opinion of the investigators, will increase risk to the subject(specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis) 3. Positive urine pregnancy test 4. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures NON-DIABETIC CONTROLS: INCLUSION CRITERIA: Two types of volunteers will be recruited: 1. Overweight and obese volunteers who will be BMI matched with study enrollees who have T2DM during analyses 2. Normal weight (BMI between 5th and 85th centiles for age) volunteers EXCLUSION CRITERIA: 1. Diabetes 2. Significant comorbidity that, in the opinion of the investigators, will increase risk to the subject (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis) 3. Current use of drugs that alter glucose metabolism (e.g. metformin) 4. Current use of prescription or non-prescription weight-loss drugs 5. Positive urine pregnancy test 6. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.