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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00445627 |
Purpose
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. Beta cells can rest by giving patients insulin shots. The study will also examine how teenagers with T2DM feel about having diabetes and explore differences between young people with and without T2DM.
This study includes patients 12 to 25 years of age with T2DM who are overweight and who were diagnosed within 2 years of enrolling in the study. Healthy individuals of normal weight or who are overweight are also eligible. Candidates are screened with a medical history, physical examination and laboratory tests.
Participants with T2DM are assigned to one of two groups. Group 1 takes an anti-diabetes medicine called metformin and follows a diet prescribed by a study staff dietitian for 2 weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a pump under the skin for 2 weeks. During these two weeks, all participants have the following tests:
Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan, psychological testing, exercise testing, and genetic testing.
| Condition | Intervention |
|---|---|
|
Obesity Insulin Resistance Overweight Diabetes Mellitus, Type 2 |
Drug: Metformin Drug: Insulin Behavioral: Nutrition counseling Behavioral: Exercise counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Natural History of Type 2 Diabetes Mellitus in Children and Young Adults |
| Estimated Enrollment: | 430 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | February 2020 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Background:
Type 2 diabetes mellitus (T2DM) is a condition characterized by insulin resistance and progressive failure of the insulin-secreting ?-cells. Previously considered a disease of adults, it is now becoming increasingly prevalent in children and adolescents. Patients with childhood onset T2DM are at very high risk for diabetes-related morbidity and mortality, due to a longer life-time duration of diabetes, as well as possible increased rapidity of Beta-cell failure.
Aims:
In this study, we will address the following aims:
To characterize hormonal, metabolic, and behavioral traits in patients with youth-onset type 2 diabetes. These will include:
Methods:
Children and young adults ages 8 to 25 years with type 2 diabetes will be studied in a cross-sectional and longitudinal manner. Two control groups without diabetes will be studied for comparison purposes: healthy lean controls, and overweight/obese controls. Methods used to study participants include routine blood sampling, oral glucose tolerance testing, mixed meal testing, arginine stimulation testing, DEXA, MRI, carotid ultrasound, questionnaires, exercise physiology, and measurements of energy expenditure. Patients with type 1 diabetes will be studied using oral glucose tolerance and mixed meal tests in a pilot study of artificial sweeteners.
Eligibility| Ages Eligible for Study: | 8 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
Type 2 diabetes mellitus as defined by:
Or
Clinical diagnosis of type 1 diabetes mellitus (for Pilot Study only)
And
EXCLUSION CRITERIA:
NON-DIABETIC CONTROLS:
INCLUSION CRITERIA:
Two types of volunteers will be recruited:
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact | |
More Information
| ClinicalTrials.gov Identifier: | NCT00445627 History of Changes |
| Other Study ID Numbers: | 070115, 07-DK-0115 |
| Study First Received: | March 8, 2007 |
| Last Updated: | December 24, 2011 |
| Health Authority: | United States: Federal Government |
|
Children Adolescents Teens Young Adults |
Type 2 Diabetes Overweight Obesity |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Obesity Overweight Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperinsulinism |
Overnutrition Nutrition Disorders Body Weight Signs and Symptoms Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |