## Protocol Section
### Identification Module
**NCT ID:** NCT02244879

**Brief Title:** Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

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

#### Organization Study ID Info
**ID:** RF-2010-2313155
#### Organization
**Class:** OTHER
**Full Name:** University of Turin, Italy
### Status Module
#### Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-03-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-03-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-02

**Type:** ACTUAL

#### Start Date
**Date:** 2013-10

**Status Verified Date:** 2016-03

#### Study First Post Date
**Date:** 2014-09-19
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-15
**Study First Submit QC Date:** 2014-09-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Ministry of Health, Italy

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Turin, Italy

#### Responsible Party

**Investigator Affiliation:** University of Turin, Italy

**Investigator Full Name:** Simona Bo

**Investigator Title:** Dr

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Type 2 Diabetes Mellitus

- Inflammation

- Insulin Resistance

- Other Disorders of Bone Density and Structure

**Keywords:**

- resveratrol

- type 2 diabetes mellitus

- inflammation

- insulin resistance

- body composition

- bone mass

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 192

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Dietary Supplement: resveratrol

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Dietary Supplement: resveratrol

**Label:** resveratrol 40

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Dietary Supplement: resveratrol

**Label:** resveratrol 500

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- placebo

- resveratrol 40

- resveratrol 500

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

**Name:** resveratrol

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Other Outcomes

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

**Measure:** body composition and bone mineral density

**Time Frame:** up to 25 months

#### Primary Outcomes

**Description:** 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

**Measure:** C reactive protein (CRP)

**Time Frame:** up to 25 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Metabolic and oxidative markers

**Time Frame:** up to 25 months

### Eligibility Module

**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

**Maximum Age:** 85 Years

**Minimum Age:** 35 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Turin

**Country:** Italy

**Facility:** University of Turin

**State:** IT

**Zip:** 10126

#### Overall Officials

**Official 1:**

**Affiliation:** University of Turin, Italy

**Name:** Simona Bo, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 29330620

**Citation:** 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.

**PMID:** 28238190

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000010335

- Term: Pathologic Processes

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Type 2 Diabetes Mellitus

- ID: M10370

- Name: Insulin Resistance

- Relevance: HIGH

- As Found: Insulin Resistance

- ID: M5126

- Name: Bone Diseases

- Relevance: HIGH

- As Found: Disorder of Bone

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001847

- Term: Bone Diseases

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

- ID: D000007333

- Term: Insulin Resistance

- ID: D000007249

- Term: Inflammation

### Intervention Browse Module - Ancestors

- ID: D000000975

- Term: Antioxidants

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000010975

- Term: Platelet Aggregation Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: LOW

- As Found: Unknown

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M1684

- Name: Resveratrol

- Relevance: HIGH

- As Found: Avastin

- ID: M4292

- Name: Antioxidants

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M13865

- Name: Platelet Aggregation Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077185

- Term: Resveratrol

### Misc Info Module

- Version Holder: 2024-05-24
