Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220961
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2005-09-14
Brief Title:
Actos Now for Prevention of Diabetes ACT NOW
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Actos Now for Prevention of Diabetes ACT NOW
Status:
COMPLETED
Status Verified Date:
2016-06
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 whether pioglitazone versus placebo can reduce the conversion rate of impaired glucose tolerance IGT to type 2 diabetes mellitus
Detailed Description:
IGT is a prediabetic state If IGT can be prevented from progressing to overt diabetes the hyperglycemia-related complications of this devastating disease can be prevented Subjects with IGT will be identified with an oral glucose tolerance test OGTT Eligible subjects also will have a measurement of first phase insulin secretion and insulin sensitivity using the frequently sampled intravenous glucose tolerance test FSIVGTT and carotid intimal media thickness using carotid ultrasound Following these measurements subjects will be randomized to receive pioglitazone or placebo and they will return every 3 months for determination of fasting plasma glucose FPG concentration and interim medical history Recruitment will take place over 15 months From the time that the recruitment period ends subjects will be followed for a total of 24 months on pioglitazone or placebo The OGTT will be repeated at 1527 and 39 months or if the FPG is 126 mgdl on the 3-month follow up visits If the diagnosis of diabetes is established before month 39 or at month 39 the FSIVGTT and carotid ultrasound will be repeated At 39 months subjects will be washed out of pioglitazone or placebo and the OGTT FSIVGTT and carotid ultrasound will be repeated at month 45
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