Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

NCT ID: NCT02244879

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-02-29

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

placebo

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

Group Type: PLACEBO_COMPARATOR

resveratrol

Intervention Type: DIETARY_SUPPLEMENT

arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day

resveratrol 40

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

Group Type: EXPERIMENTAL

resveratrol

Intervention Type: DIETARY_SUPPLEMENT

arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day

resveratrol 500

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

Group Type: EXPERIMENTAL

resveratrol

Intervention Type: DIETARY_SUPPLEMENT

arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day

Interventions

resveratrol

arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Simona Bo

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simona Bo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Turin, Italy

Locations

University of Turin

Turin, IT, Italy

Countries

Italy

References

Bo S, Togliatto G, Gambino R, Ponzo V, Lombardo G, Rosato R, Cassader M, Brizzi MF. Impact of sirtuin-1 expression on H3K56 acetylation and oxidative stress: a double-blind randomized controlled trial with resveratrol supplementation. Acta Diabetol. 2018 Apr;55(4):331-340. doi: 10.1007/s00592-017-1097-4. Epub 2018 Jan 12.

Reference Type: DERIVED

PMID: 29330620 (View on PubMed)

Bo S, Ponzo V, Evangelista A, Ciccone G, Goitre I, Saba F, Procopio M, Cassader M, Gambino R. Effects of 6 months of resveratrol versus placebo on pentraxin 3 in patients with type 2 diabetes mellitus: a double-blind randomized controlled trial. Acta Diabetol. 2017 May;54(5):499-507. doi: 10.1007/s00592-017-0977-y. Epub 2017 Feb 25.

Reference Type: DERIVED

PMID: 28238190 (View on PubMed)

Other Identifiers

RF-2010-2313155

Identifier Type: -

Identifier Source: org_study_id