Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244879
• Other study ID #: RF-2010-2313155
• Status: Completed
• Phase: Phase 3
• First received: September 15, 2014
• Last updated: March 6, 2016
• Start date: October 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• resveratrol
arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day

Locations

Country	Name	City	State
Italy	University of Turin	Turin	IT

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	body composition and bone mineral density	To evaluate before-after change in bone mineral density and body composition by Dual-emission X-ray absorptiometry	up to 25 months	No
Primary	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	No
Secondary	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	No