Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004984
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2000-03-13
Brief Title:
The Diabetes Prevention Trial of Type 1 Diabetes DPT-1
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
The Diabetes Prevention Trial of Type 1 Diabetes DPT-1
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPT-1
Brief Summary:
The Diabetes Prevention Trial of Type 1 DPT-1 was 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 Subjects were recruited from study clinics and through media campaignsFirst-degree relatives 3 to 45 years of age and second-degree relatives 3 to 20 years of age of patients with diabetes were screened for islet-cell antibodies Those individuals found to be at high risk of diabetes were randomized to receive either close observation or low-dose parenteral insulin Those individuals found to be at intermediate risk of diabetes are randomized to receive insulin orally or to receive placebo Patients were followed for up to six years
Detailed Description:
The study was divided into three parts screening staging and intervention Subjects were recruited from study clinics and through media campaignsFirst-degree relatives 3 to 45 years of age and second-degree relatives 3 to 20 years of age of patients with diabetes were screened for islet-cell antibodies Those with an islet-cell antibody titer of 10 Juvenile Diabetes Foundation JDF units or higher were offered staging evaluations
Staging confirmed the presence of islet-cell antibodies measured insulin antibodies assessed the first-phase insulin response to intravenous glucose assessed oral glucose tolerance and determined the presence or absence of HLA-DQA10102 DQB10602 a protective haplotype the presence of which excluded subjects from further participation
Islet-cell antibody-positive subjects were then defined as having a high risk of diabetes a five-year risk of more than 50 percent and were deemed eligible for the parenteral insulin trial if they had a first-phase insulin response below the threshold as defined below on two occasions if their oral glucose-tolerance results were not completely normalor both
Relatives who tested positive for islet-cell antibodies and insulin antibodies and who had a first-phase insulin response above the threshold and normal glucose tolerance were defined as having intermediate risk a five-year risk of 26 to 50 percent and were deemed eligible for the ongoing oral insulin trial
All randomized subjects were seen every six months at which time an oral glucose-tolerance test was administered to assess glycemic status the primary study end point Mixed-meal tolerance tests were performed at base line at years 1 3 and 5 and at the end of the study Intravenous glucose-tolerance testing was performed at years 2 4 and 6 and at the end of the study
Staging confirmed the presence of islet-cell antibodies measured insulin antibodies assessed the first-phase insulin response to intravenous glucose assessed oral glucose tolerance and determined the presence or absence of HLA-DQA10102 DQB10602 a protective haplotype the presence of which excluded subjects from further participation
Islet-cell antibody-positive subjects were then defined as having a high risk of diabetes a five-year risk of more than 50 percent and were deemed eligible for the parenteral insulin trial if they had a first-phase insulin response below the threshold as defined below on two occasions if their oral glucose-tolerance results were not completely normalor both
Relatives who tested positive for islet-cell antibodies and insulin antibodies and who had a first-phase insulin response above the threshold and normal glucose tolerance were defined as having intermediate risk a five-year risk of 26 to 50 percent and were deemed eligible for the ongoing oral insulin trial
All randomized subjects were seen every six months at which time an oral glucose-tolerance test was administered to assess glycemic status the primary study end point Mixed-meal tolerance tests were performed at base line at years 1 3 and 5 and at the end of the study Intravenous glucose-tolerance testing was performed at years 2 4 and 6 and at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK060782 | NIH | None | None |
| U01DK060916 | NIH | None | None |
| U01DK060987 | NIH | None | None |
| U01DK061010 | NIH | None | None |
| U01DK061029 | NIH | None | None |
| U01DK061030 | NIH | None | None |
| U01DK061034 | NIH | None | None |
| U01DK061035 | NIH | None | None |
| U01DK061036 | NIH | None | None |
| U01DK061037 | NIH | None | None |
| U01DK061038 | NIH | None | None |
| U01DK061040 | NIH | None | None |
| U01DK061041 | NIH | None | None |
| U01DK061042 | NIH | None | None |
| U01DK061058 | NIH | None | None |
| U01DK061055 | NIH | None | httpsreporternihgovquickSearchU01DK061055 |