Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

• Sponsor: University of Turin, Italy (Other)
• Overall Status: Completed
• CT.gov ID: NCT02244879
• Collaborator: Ministry of Health, Italy (Other)
• Enrollment: 192
• Location: 1
• Arms: 3
• Duration (Months): 28
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus; Inflammation; Insulin Resistance; Other Disorders of Bone Density and Structure	Dietary Supplement: resveratrol	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients. A Double-blind Randomized Controlled Trial
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo In this arm, 64 patients will receive a tablet of placebo once/day for 6 months	Dietary Supplement: resveratrol; arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day
Experimental: resveratrol 40 In this arm, 64 patients will receive a tablet of 40mg resveratrol once/day for 6 months	Dietary Supplement: resveratrol; arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day
Experimental: resveratrol 500 In this arm, 64 patients will receive a tablet of 500 mg resveratrol once/day for 6 months	Dietary Supplement: resveratrol; arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Other Outcome Measures

1. body composition and bone mineral density [up to 25 months]

   To evaluate before-after change in bone mineral density and body composition by Dual-emission X-ray absorptiometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Turin	Turin	IT	Italy	10126

Sponsors and Collaborators

• University of Turin, Italy
• Ministry of Health, Italy

Investigators

• Principal Investigator: Simona Bo, MD, University of Turin, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Simona Bo, Dr, University of Turin, Italy
• ClinicalTrials.gov Identifier: NCT02244879
• Other Study ID Numbers: RF-2010-2313155
• First Posted: Sep 19, 2014
• Last Update Posted: Mar 8, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Simona Bo, Dr, University of Turin, Italy: resveratrol; type 2 diabetes mellitus; inflammation; insulin resistance; body composition; bone mass
• Additional relevant MeSH terms: Bone Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation; Resveratrol

Study Results

No Results Posted as of Mar 8, 2016