Can a Two-Week insulin vacation help young diabetics?
NCT ID NCT00445627
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
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Jun 2007
- Lead sponsor
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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
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8 to 25 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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