Resveratrol in Type2 Diabetes and Obesity | NCT01158417

Studies
Resveratrol in Type2 Diabetes and Obesity

NCT01158417

Sponsor

University at Buffalo

Status

Terminated

Last Update Posted

Nov 9, 2022Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Type 2 Diabetes
Obesity
Insulin Resistance

Interventions

Placebo
Resveratrol 40 mg oral three times a day
Resveratrol 500 mg oral once daily.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

FDA clinical hold requiring IND submission, product not available in the market anymore

Expanded Access Info

Start Date

Dec 2008Actual

Primary Completion Date

Jul 8, 2012Actual

Completion Date

Jul 8, 2012Actual

First Submitted Date

Jul 7, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2022

Last Update Posted Date

Nov 9, 2022Actual

Name	Class
Kaleida Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo tablets	Drug: Placebo
Resveratrol 40 mg oral three times a day	Experimental	Resveratrol	Drug: Resveratrol 40 mg oral three times a day
resveratrol 500 mg oral once daily.	Experimental	Resveratrol	Drug: Resveratrol 500 mg oral once daily.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	oral	Placebo
Resveratrol 40 mg oral three times a day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NF-Kb	To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	12 weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paresh Dandona, MD	Kaleida Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jeanne Hejna		Williamsville	New York	14221	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D007333	Insulin Resistance
D007249	Inflammation

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077185	Resveratrol

Ancestor Terms

ID	Term
D000081225	Stilbestrols
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided