Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340132
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2006-06-19
Brief Title:
Cross-Sectional and Longitudinal Studies of Pre-Diabetes in the Pima Indians
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cross-Sectional and Longitudinal Studies of Pre-Diabetes
Status:
COMPLETED
Status Verified Date:
2024-04-18
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:
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes These results suggest that both inherent apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis and acquired evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes To identify the genetic and environmental determinants of diabetes we are continuing to determine 1 if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and 2 the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion
TAB
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition oral and intravenous glucose tolerance and in vivo insulin action In addition in selected subjects adipose andor skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity insulin secretion insulin resistance andor type 2 diabetes
TAB
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition oral and intravenous glucose tolerance and in vivo insulin action In addition in selected subjects adipose andor skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity insulin secretion insulin resistance andor type 2 diabetes
Detailed Description:
Insulin resistance and a defect in early insulin secretion are risk factors for the development of type 2 diabetes mellitus A recent longitudinal analysis which tracked the development of diabetes demonstrated that both insulin action and early insulin secretion deteriorate as individuals progress from normal to impaired glucose tolerance and then to diabetes These results suggest that both inherent apparent in normal glucose tolerant subjects who progress to diabetes and likely to have a genetic basis and acquired evident as individuals progress from NGT to IGT to diabetes and possibly environmental in origin defects in insulin action and secretion contribute to the pathogenesis of type 2 diabetes To identify the genetic and environmental determinants of diabetes we are continuing to determine 1 if there are genes that segregate with metabolic risk factors for diabetes which might therefore be genetic markers for type 2 diabetes and 2 the mechanisms mediating genetic and environmental determinants of insulin resistance and impaired insulin secretion
TAB
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition oral and intravenous glucose tolerance and in vivo insulin action In addition in selected subjects adipose andor skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity insulin secretion insulin resistance andor type 2 diabetes
TAB
Volunteers for this study will be admitted to the clinical research ward where they will undergo several tests to determine body composition oral and intravenous glucose tolerance and in vivo insulin action In addition in selected subjects adipose andor skeletal muscle tissue will be obtained by percutaneous biopsy for in vitro studies of gene expression and insulin action in these tissues A transformed lymphocyte cell line will be established for each subject as a permanent source of DNA for genetic studies Genetic markers for type 2 diabetes and insulin resistance will be sought by typing each individual at positional and functional candidate loci in the hopes of finding an association between these loci and obesity insulin secretion insulin resistance andor type 2 diabetes
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 |
|---|---|---|---|
| OH82-DK-0136 | None | None | None |