Type 2 Diabetes Clinical Trial
Official title:
Effects of Resveratrol in Patients With Type 2 Diabetes: The RED Trial
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.
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. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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