Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038727
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-12-28
First Post:
2002-06-04
Brief Title:
Diabetes Prevention Program Outcomes Study
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:
Diabetes Prevention Program Outcomes Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-12
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:
DPPOS
Brief Summary:
The Diabetes Prevention Program DPP was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance IGT 2 hour glucose of 140-199 mgdl The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58 and metformin reduced diabetes onset by 31
DPPOS 2002-2013 is designed to take advantage of the scientifically and clinically valuable DPP participants This group of participants is nearly 50 minority and represents the largest at risk population ever studied Clinically important research questions remain that focus on 1 durability of the prior DPP intervention 2 determination of the clinical course of precisely known new onset diabetes in particular regarding microvascular disease CVD risk factors and atherosclerosis 3 close examination of these topics in men vs women and in minority populations
The major aims of DPPOS-3 2014-2025 take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort The metformin exposure and high degree of study retention and adherence 85 of the DPPOS cohort continues to attend annual and mid-year visits allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease CVD and cancer outcomes outcomes of great clinical interest and import
DPPOS 2002-2013 is designed to take advantage of the scientifically and clinically valuable DPP participants This group of participants is nearly 50 minority and represents the largest at risk population ever studied Clinically important research questions remain that focus on 1 durability of the prior DPP intervention 2 determination of the clinical course of precisely known new onset diabetes in particular regarding microvascular disease CVD risk factors and atherosclerosis 3 close examination of these topics in men vs women and in minority populations
The major aims of DPPOS-3 2014-2025 take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort The metformin exposure and high degree of study retention and adherence 85 of the DPPOS cohort continues to attend annual and mid-year visits allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease CVD and cancer outcomes outcomes of great clinical interest and import
Detailed Description:
The current DPPOS Executive Summary and protocol as well as DPPOS protocol and lifestyle manuals and publications are available at httpwwwdpposorg
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 |
|---|---|---|---|
| U01DK048489 | NIH | None | httpsreporternihgovquickSearchU01DK048489 |