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Home > "T" Clinical Trials Conditions > The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1) The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
For Condition: Diabetes Mellitus, Type 1
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , National Center for Research Resources (NCRR),National Institute of Allergy and Infectious Diseases (NIAID),National Institute of Child Health and Human Development (NICHD),National Center on Minority Health and Health Disparities (NCMHD),Office of Research on Women's Health (ORWH)
Synopsis: The Diabetes Prevention Trial of Type 1 (DPT-1) is a multicenter randomized, controlled clinical trial designed to determine whether it is possible to delay or prevent the clinical onset of type 1 diabetes through daily doses of insulin in individuals determined to be at risk for the disease. The parenteral insulin trial in DPT-1 has been completed, however, the oral insulin trial is still recruiting. Over 350 sites in the United States, Canada, and Puerto Rico are taking part in the study. Screening of patients is ongoing; approximately 100,000 nondiabetic relatives of persons with type 1 diabetes have been screened to detect the presence of islet cell antibodies. Those individuals found to have islet cell antibodies are being staged to determine their risk of diabetes based on genetic, immunologic, and metabolic characteristics. Those individuals found to be at intermediate risk of diabetes are randomized to receive insulin orally or to receive placebo. Patients are being followed for up to six years.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 3 Years/45 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Individuals 3-45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling) - Individuals 3-20 years old who have an extended family member with type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling) Exclusion Criteria: - To be eligible, a person must: - Not have diabetes already. - Have no previous history of being treated with insulin or oral diabetes medications. - Have not received any prior therapy for prevention of type 1 diabetes such as insulin, nicotinamide, or immunosuppressive drugs (i.e. have not been involved in any previous clinical studies of these agents.) - Have no known serious diseases. - If you are a woman, you must not be planning to become pregnant during the course of the study. You will not be excluded from participation, but are not encouraged to volunteer in the first place if you plan to have a baby during the trial period).
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaySkyler, Study Chair, University of Miami School of Medicine
University of Miami School of Medicine, Jackson Medical Tower
Miami, Florida, 33136
United States
Children's Hospital of Pittsburgh, Dept/Pediatric Endocrinology, 3705 5th Ave
Pittsburgh, Pennsylvania, 15213
United States
University of Colorado Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262
United States
Stanford University
Stanford, California, 94305-5208
United States
Virginia Mason Research Center, 1201 Ninth Avenue
Seattle, Washington, 98101
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Indiana University, James Whitcomb Riley Hospital for Children, 702 Barnhill Dr, Ste 5960
Indianapolis, Indiana, 46202
United States
University of Texas, Children's Medical Center, 6300 Harry Hines Ste 1200
Dallas, Texas, 75235
United States
Naomi Berrie Diabetes Center, Columbia University, 1150 St. Nicholas Ave
New York City, New York, 10032
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
Childrens Hospital of Los Angeles, Division of Endocrinology
Los Angeles, California, 90027
United States
DPT-1 Operations Coordinating Center
Miami, Florida, 33136
United States
University of Florida Diabetes Research Center
Gainesville, Florida, 32610-0296
United States
University of California-San Francisco, Milberry Union East RM 405, 500 Parnassus Ave Box 0136
San Francisco, California, 94143
United States
Hospital for Sick Children, Division of Endocrinology, 555 University Ave, Rm 5110
Toronto, Ontario, M5G-1X8
Canada
Additional Information:
Study ID Numbers: DPT-1; DK60782,DK60916,DK60987,DK61010,DK61029,DK61030,DK61034,DK61035,DK61036,DK61037,DK61038,DK61040,DK61041,DK61042,DK61058,DK61055
Study Start Date: February 1994
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004984
Other Diabetes Mellitus, Type 1 Studies:
1. Islet Transplantation for patients with Type 1 diabetes
2. Ingested Interferon Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Type 1 Diabetes Mellitus
3. Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
4. Islet Cell Transplantation Alone in Patients with Type I Diabetes Mellitus: steroid-free immunosuppression
5. Evaluation of the Effect of Pramlintide on Satiety and Food Intake
Related Studies:
Other Diabetes Mellitus, Type 1 Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
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