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NCT00445627 · ClinicalTrials.gov registry record
Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 82
- Enrollment target
NCT00445627 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 82 participants.
The verdict
NCT00445627 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 82 participants
- Enrollment target
Study 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. 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: * Frequent blood sugar checks. * Oral glucose tolerance test (routine diabetes test in which blood samples are drawn before and several times after the subject drinks a sugary solution). * Arginine stimulation to test the response of the body to arginine, a normal ingredient of food that stimulates the release of insulin. Two catheters are placed into veins in the arms, one to administer a liquid containing arginine, the other to draw the blood samples. * Ultrasound of the blood vessels in the neck to check for hardening of the arteries. * Metabolism test to measure the amount of oxygen used during rest. The subject breathes normally during rest while wearing a canopy over his or her head for about 20 minutes. * MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and end of the study) * DEXA scan to determine percent body fat. * Tests to explore quality of life and
Interventions
- DRUG Metformin
- DRUG Insulin
- BEHAVIORAL Nutrition counseling
- BEHAVIORAL Exercise counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2007-06-18 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00445627
The ClinicalTrials.gov registry entry for NCT00445627 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.
NCT00445627 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00445627 about?
NCT00445627 is a clinical study titled "Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus". 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 wit...
What is the current status of trial NCT00445627?
This trial is currently completed. The enrollment target is 82 participants. The study started on 2007-06-18.
What interventions are being tested in trial NCT00445627?
The interventions under investigation include: Metformin (DRUG), Insulin (DRUG), Nutrition counseling (BEHAVIORAL), Exercise counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT00445627?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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