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Resveratrol in Type2 Diabetes and Obesity

Primary Purpose

Type 2 Diabetes, Obesity, Insulin Resistance

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Resveratrol 40 mg oral three times a day
Resveratrol 500 mg oral once daily.
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Obesity, Insulin Resistance, Resveratrol, Inflammation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 20 years of age and older
  2. Healthy Obese subjects with BMI > 30
  3. Type 2 Diabetics with BMI > 30
  4. Subjects with good peripheral vein.
  5. Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.

Exclusion Criteria:

  1. Subjects on any antioxidant medication
  2. Patient on non-steroidal anti-inflammatory drug
  3. On any agent with significant antioxidant properties.
  4. History of drug or alcohol abuse
  5. Any life threatening disease
  6. Allergy to peanuts, grapes, wine, mulberries.
  7. Pregnant women.
  8. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks.
  9. Subjects on anticoagulants.

Sites / Locations

  • Jeanne Hejna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Resveratrol 40 mg oral three times a day

resveratrol 500 mg oral once daily.

Arm Description

Placebo tablets

Resveratrol

Resveratrol

Outcomes

Primary Outcome Measures

NF-Kb
To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB

Secondary Outcome Measures

GLP-1
To see whether Resveratrol leads to a greater stimulation of the incretin system and secretion/release of GIP and GLP-1 when compared to that following placebo

Full Information

First Posted
July 7, 2010
Last Updated
November 3, 2022
Sponsor
University at Buffalo
Collaborators
Kaleida Health
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1. Study Identification

Unique Protocol Identification Number
NCT01158417
Brief Title
Resveratrol in Type2 Diabetes and Obesity
Official Title
Effect of Resveratrol on Insulin Resistance and Inflammatory Mediators in Obese and Type 2 Diabetic Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
FDA clinical hold requiring IND submission, product not available in the market anymore
Study Start Date
December 2008 (Actual)
Primary Completion Date
July 8, 2012 (Actual)
Study Completion Date
July 8, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Kaleida Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.
Detailed Description
The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity, Insulin Resistance
Keywords
Type 2 Diabetes, Obesity, Insulin Resistance, Resveratrol, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Arm Title
Resveratrol 40 mg oral three times a day
Arm Type
Experimental
Arm Description
Resveratrol
Arm Title
resveratrol 500 mg oral once daily.
Arm Type
Experimental
Arm Description
Resveratrol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Resveratrol 40 mg oral three times a day
Other Intervention Name(s)
Resveratrol 40mg
Intervention Description
Drug
Intervention Type
Drug
Intervention Name(s)
Resveratrol 500 mg oral once daily.
Other Intervention Name(s)
Resveratrol 500 mg
Intervention Description
Resveratrol 500 mg oral once daily.
Primary Outcome Measure Information:
Title
NF-Kb
Description
To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
GLP-1
Description
To see whether Resveratrol leads to a greater stimulation of the incretin system and secretion/release of GIP and GLP-1 when compared to that following placebo
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20 years of age and older Healthy Obese subjects with BMI > 30 Type 2 Diabetics with BMI > 30 Subjects with good peripheral vein. Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study. Exclusion Criteria: Subjects on any antioxidant medication Patient on non-steroidal anti-inflammatory drug On any agent with significant antioxidant properties. History of drug or alcohol abuse Any life threatening disease Allergy to peanuts, grapes, wine, mulberries. Pregnant women. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks. Subjects on anticoagulants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh Dandona, MD
Organizational Affiliation
Kaleida Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeanne Hejna
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Resveratrol in Type2 Diabetes and Obesity

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