Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2006-08-03
Brief Title:
Epidemiology of Diabetes Interventions and Complications EDIC
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
Epidemiology of Diabetes Interventions and Complications EDIC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The Diabetes Control and Complications Trial DCCT1983-1993 compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes T1DM over a mean follow-up of 65 years Intensive therapy reduced the risks of retinopathy nephropathy and neuropathy by 35-76 The level of glycemia was the primary determinant of complications We also described the adverse effects of intensive therapy assessed its effects on cardiovascular disease CVD risk factors neurocognition and quality of life and projected the lifetime health-economic impact After the primary DCCT results were reported in 1993 intensive therapy aiming for a HbA1c 7 was adopted world-wide as standard-of-care for T1DM
The Epidemiology of Diabetes Interventions and Complications EDIC 1994-present is the observational follow-up study of the DCCT cohort Micro- and cardio-vascular complications and a wide range of established and putative risk factors including genetic and epigenetic factors have been measured with standardized methods carefully documented and events adjudicated EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for 15 years despite the convergence of HbA1c levels in the two groups during EDIC a novel concept termed metabolic memory Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality
The overarching goals for the current cycle 2022-2027 are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age With increasing longevity the increased adiposity that has affected patients with T1DM including EDIC participants has potential adverse consequences Thus the impact of diabetes duration aging and adiposity on morbidities and their underlying risk factors will be studied The results will guide treatment priorities as T1DM patients age
The Epidemiology of Diabetes Interventions and Complications EDIC 1994-present is the observational follow-up study of the DCCT cohort Micro- and cardio-vascular complications and a wide range of established and putative risk factors including genetic and epigenetic factors have been measured with standardized methods carefully documented and events adjudicated EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for 15 years despite the convergence of HbA1c levels in the two groups during EDIC a novel concept termed metabolic memory Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality
The overarching goals for the current cycle 2022-2027 are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age With increasing longevity the increased adiposity that has affected patients with T1DM including EDIC participants has potential adverse consequences Thus the impact of diabetes duration aging and adiposity on morbidities and their underlying risk factors will be studied The results will guide treatment priorities as T1DM patients age
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| U01DK094176 | NIH | None | httpsreporternihgovquickSearchU01DK094176 |