Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212290
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2005-09-20
Brief Title:
Insulin Resistance and Central Nervous System CNS Function in Type 2 Diabetes
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:
None
Status:
COMPLETED
Status Verified Date:
2010-02
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 purpose of this study is to examine the effects of treating insulin resistance on memory and attention brain glucose utilization and proteins in spinal fluid
Detailed Description:
Insulin resistant conditions such as impaired glucose tolerance type 2 diabetes mellitus and hyperinsulinemia have been associated with an increased risk for memory decline and for Alzheimers disease The main study will determine whether treatment with pioglitazone or nateglinide will improve verbal memory and selective attention for older adults with impaired glucose tolerance or mild type 2 diabetes The main study will also characterize changes in blood concentrations of insulin inflammatory markers and the beta-amyloid peptides that are related to Alzheimers disease In one sub-study participants will undergo brain positron emission tomography PET imaging before and after 16 weeks of treatment with pioglitazone nateglinide or placebo The purpose of this sub-study is to determine the effects of treatment on brain glucose utilization In a second sub-study participants will undergo a lumbar puncture procedure before and after treatment The purpose of this sub-study is to determine the effects of treatment on spinal fluid concentrations of insulin inflammatory markers and beta-amyloid peptides Together these main and sub-studies should characterize the effects of insulin resistance on cognition and suggest a mechanism by which insulin resistant conditions increase risk for memory decline and for Alzheimers disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None