Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01677611
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2012-08-30
Brief Title:
Effects of Resveratrol in Patients With Type 2 Diabetes
Sponsor:
Khoo Teck Puat Hospital
Organization:
Khoo Teck Puat Hospital
Study Overview
Official Title:
Effects of Resveratrol in Patients With Type 2 Diabetes The RED Trial
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RED
Brief Summary:
Animal studies indicate that resveratrol a phytoalexin enriched in the skin of red grapes and a constituent of red wine is associated with longevity likely through the increased production of a protein SIRT1
The trial is a proof-of-concept study primarily designed to examine for the first time in humans the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10 patients with T2DM in a randomized placebo-controlled double-blind fashion Secondary outcomes include measures of AMPK p-AMPK and GLUT4 expression levels energy expenditure physical activity levels distribution of abdominal adipose tissue and skeletal muscle fiber type composition body weight HbA1c plasma lipid subfraction adiponectin levels and insulin sensitivity
The trial is a proof-of-concept study primarily designed to examine for the first time in humans the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10 patients with T2DM in a randomized placebo-controlled double-blind fashion Secondary outcomes include measures of AMPK p-AMPK and GLUT4 expression levels energy expenditure physical activity levels distribution of abdominal adipose tissue and skeletal muscle fiber type composition body weight HbA1c plasma lipid subfraction adiponectin levels and insulin sensitivity
Detailed Description:
Eligible criteria include Chinese males aged between 40 and 69 years old with T2DM with a HbA1c of 71 to 12 and who have been on a stable oral hypoglycemic regimen for the past 3 months Subjects who were insulin-dependent with renal or liver impairment or who were terminally ill were excluded
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