NCT01677611

Effects of Resveratrol in Patients With Type 2 Diabetes

Effects of Resveratrol in Patients With Type 2 Diabetes: The RED Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Khoo Teck Puat Hospital · Academic / Other
• Sex: Male
• Age: 40 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible criteria include Chinese males, aged between 40 and 69 years old, with T2DM with a HbA1c of 7.1 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Trans-resveratrol extract from Polygonum Cuspidatum	Starting dose of 500 mg daily of either resveratrol to be administered on Day 1 and increased by 500 mg per day every 3 days to a maximum dose of 3 g per day in three divided doses if there was no hypoglycemia.
DRUG	Placebo

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-09-01
• Completion: 2012-03-01
• First posted: 2012-09-03
• Last updated: 2012-09-03

Locations

1 site across 1 country: Singapore