Status:
COMPLETED
Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Overweight
Eligibility:
All Genders
8-25 years
Brief Summary
This study will determine whether resting beta cells (cells in the pancreas that produce insulin) for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus (T2DM) to make insulin....
Detailed Description
Background: Type 2 diabetes mellitus (T2DM) is a condition characterized by insulin resistance and progressive failure of the insulin-secreting beta-cells. Previously considered a disease of adults, ...
Eligibility Criteria
Inclusion
- DIABETIC SUBJECTS:
- INCLUSION CRITERIA:
- Type 2 diabetes mellitus as defined by:
- 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).
- 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.
- Absence of insulin autoantibodies (in insulin na(SqrRoot) ve patients only)
- Or
- Clinical diagnosis of type 1 diabetes mellitus (for Pilot Study only)
- And
- Age 8-25 years at enrollment
- EXCLUSION CRITERIA:
- Normal OGTT at NIH (fasting blood glucose \< 100 mg/dL AND 2 hour blood glucose \< 140 mg/dL)
- 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)
- Positive urine pregnancy test
- 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:
- Overweight and obese volunteers who will be BMI matched with study enrollees who have T2DM during analyses
- Normal weight (BMI between 5th and 85th centiles for age) volunteers
- EXCLUSION CRITERIA:
- Diabetes
- 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)
- Current use of drugs that alter glucose metabolism (e.g. metformin)
- Current use of prescription or non-prescription weight-loss drugs
- Positive urine pregnancy test
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
Exclusion
Key Trial Info
Start Date :
June 18 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00445627
Start Date
June 18 2007
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892