Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients. A Double-blind Randomized Controlled Trial

Conditions
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Type 2 Diabetes Mellitus, Inflammation, Insulin Resistance, Other Disorders of Bone Density and Structure

Intervention / Treatment
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* Dietary Supplement: resveratrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 35 years of age and older Type 2 diabetes with body mass index (BMI)<35 kg/m2 Subjects on hypoglycemic agents other than insulin Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements. Exclusion Criteria: Subjects on any antioxidant medication Patient on non-steroidal anti-inflammatory drug, steroids or insulin On any agent with significant antioxidant properties History of drug or alcohol abuse Liver or kidney diseases Any life threatening diseases Allergy to peanuts, grapes, wine, mulberries Pregnant women Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four Weeks Subjects on anticoagulants

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>In this arm, 64 patients will receive a tablet of placebo once/day for 6 months | Dietary Supplement: resveratrol<br>* arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day<br>|
| Experimental: resveratrol 40<br>In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months | Dietary Supplement: resveratrol<br>* arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day<br>|
| Experimental: resveratrol 500<br>In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months | Dietary Supplement: resveratrol<br>* arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein (CRP) | To investigate changes from baseline in blood concentrations of high-sensitivity CRP after six months of treatment with either resveratrol at different dosages or placebo | up to 25 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic and oxidative markers | To evaluate before-after changes in the concentrations of the following: Interleukin 6, Pentraxin-3, total antioxidant status, fasting glucose, insulin, glycated hemoglobin, total and HDL-cholesterol, triglycerides, adiponectin. | up to 25 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resveratrol, type 2 diabetes mellitus, inflammation, insulin resistance, body composition, bone mass