Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

Phase 3

Completed

• Conditions: Insulin Resistance; Type 2 Diabetes Mellitus; Other Disorders of Bone Density and Structure; Inflammation
• Interventions: Dietary Supplement: resveratrol

• Registration Number: NCT02244879
• Lead Sponsor: University of Turin, Italy

Brief 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-06
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resveratrol 500	resveratrol	In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months
placebo	resveratrol	In this arm, 64 patients will receive a tablet of placebo once/day for 6 months
resveratrol 40	resveratrol	In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months

Primary Outcome Measures

Name	Time	Method
C reactive protein (CRP)	up to 25 months	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

Secondary Outcome Measures

Name	Time	Method
Metabolic and oxidative markers	up to 25 months	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.

Trial Locations

Locations (1)

University of Turin; 🇮🇹 Turin, IT, Italy