Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

University of Turin

Status and phase: Completed; Phase 3

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

Treatments: Dietary Supplement: resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT02244879

RF-2010-2313155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 35 years of age and older
2. Type 2 diabetes with body mass index (BMI)<35 kg/m2
3. Subjects on hypoglycemic agents other than insulin
4. Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Exclusion criteria

1. Subjects on any antioxidant medication
2. Patient on non-steroidal anti-inflammatory drug, steroids or insulin
3. On any agent with significant antioxidant properties
4. History of drug or alcohol abuse
5. Liver or kidney diseases
6. Any life threatening diseases
7. Allergy to peanuts, grapes, wine, mulberries
8. Pregnant women
9. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four Weeks
10. Subjects on anticoagulants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

In this arm, 64 patients will receive a tablet of placebo once/day for 6 months

Treatment:

Dietary Supplement: resveratrol

resveratrol 40

Experimental group

Description:

In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months

Treatment:

Dietary Supplement: resveratrol

resveratrol 500

Experimental group

Description:

In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months

Treatment:

Dietary Supplement: resveratrol