Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients. A Double-blind Randomized Controlled Trial
This research will investigate the effect of resveratrol on inflammatory mediators in type 2
diabetic patients in vivo.
The investigators will also investigate the hypothesis that resveratrol has an antioxidant
activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.
Despite a large body of evidence demonstrating promising effects of resveratrol in rodents,
human studies are still lacking and both preventive and therapeutic value of resveratrol in
humans remains to be elucidated. The published evidence is not sufficiently strong to
recommend for the administration of resveratrol to humans, beyond dietary sources. On the
other hand, animal data are promising in prevention of various cancer types, coronary heart
diseases and diabetes which strongly indicate the need for human clinical trials.
Furthermore, data are lacking either about safety during long-term administration, or on the
efficacy of resveratrol administration in patients with chronic illnesses, such as diabetes
mellitus.
The main objective of this study is to investigate the effect of resveratrol on inflammatory
mediators in type 2 diabetic patients in vivo.
This research will investigate the hypothesis that resveratrol, when given orally to type 2
diabetic subjects for 24 weeks induces a decrease in values of high-sensitivity CRP
(C-reactive protein) (primary outcome measure), IL-6 (Interleukin-6), PTX3 (pentraxin 3).
The investigators will also investigate the hypothesis that resveratrol has an antioxidant
activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.
Secondary outcomes are therefore variations in the following variables: TAS (total
antioxidant status), glycemia, glycated hemoglobin (HbA1c), Homeostasis model assessment of
insulin resistance (HOMA-IR), total and HDL-cholesterol, triglycerides, adiponectin, body
composition (evaluated by Dual-emission X-ray absorptiometry DXA-), bone mineral density
(DXA).
Finally, the investigators are interested in evaluating efficacy, safety and tolerability of
two different dosages of resveratrol: 500 mg/day and 40 mg/day.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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