Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Inflammation; Insulin Resistance; Other Disorders of Bone Density and Structure
MeSH terms: Bone Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): resveratrol
Intervention type(s): Dietary Supplement
Intervention description(s): arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: resveratrol; type 2 diabetes mellitus; inflammation; insulin resistance; body composition; bone mass