Ginkgo Biloba Extract and the Insulin Resistance Syndrome

This study has been completed.

Sponsor:

Information provided by:

National Center for Complementary and Alternative Medicine (NCCAM)

ClinicalTrials.gov Identifier:

NCT00032474

First received: March 21, 2002

Last updated: August 17, 2006

Last verified: July 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2002

Last Updated Date

August 17, 2006

Start Date ^ICMJE

December 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00032474 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ginkgo Biloba Extract and the Insulin Resistance Syndrome

Official Title ^ICMJE

Ginkgo Biloba Extract and the Insulin Resistance Syndrome

Brief Summary

The purpose of this study is to examine whether the ingestion of the herbal dietary supplement Ginkgo biloba extract has any effect on the efficacy of three classes of diabetic medications - (Glucotrol, Glucophage and Actose). Additionally, the study will examine the effect of Ginkgo biloba extract on pancreatic insulin production in non-diabetic subjects between the ages of 20 and 75 years old.

Detailed Description

Herbal remedy is popular among those with chronic diseases, who may already be taking several prescription medications, thereby increasing the risk of drug-herb interactions. Ginkgo biloba extract is a popular dietary supplement that is ingested by the general population to enhance mental focus and by the elderly to delay onset of age-acquired loss of cognitive function. In subjects with non-insulin dependent diabetes (NIDDM), ingestion of Ginkgo biloba may decrease efficacy of the hypoglycemic agents and increase whole body insulin resistance. Because aging is a significant risk factor for the development of NIDDM as a result of a progressive decline in pancreatic function, and because the elderly chronically take multiple prescription medications, the increased use of Ginkgo biloba in this population may increase drug-herb interactions. Therefore, we shall examine the effect of Ginkgo biloba on the pancreatic function in the elderly to determine whether it may produce pancreatic dysfunction and a potential for the development of insulinopenia. The results of this study should provide valuable information for designing new therapeutic strategies for the treatment of diseases in the insulin resistance syndrome.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Ginkgo biloba extract

Study Arm (s)

Not Provided

Publications *

Kudolo GB. The effect of 3-month ingestion of Ginkgo biloba extract on pancreatic beta-cell function in response to glucose loading in normal glucose tolerant individuals. J Clin Pharmacol. 2000 Jun;40(6):647-54.
Kudolo GB. The effect of 3-month ingestion of Ginkgo biloba extract (EGb 761) on pancreatic beta-cell function in response to glucose loading in individuals with non-insulin-dependent diabetes mellitus. J Clin Pharmacol. 2001 Jun;41(6):600-11.
Kudolo GB. Ingestion of Ginkgo biloba extract accelerates pancreatic function in normal and type II diabetic subjects. Clinical Chemistry 2000; 46 (Suppl) Abstract no. 434.
Kudolo GB. Ginkgo biloba increases glucose-stimulated insulin production in diabetic subjects with pancreatic exhaustion. Alternative Therapies in Health and Medicine. 2001; 7:S19.
Kudolo GB. Ingestion of Ginkgo biloba extract significantly inhibits collagen-induced platelet aggregation and thromboxane A2 synthesis. Alternative Therapies in Health and Medicine 2001; 7:105.
George B. Kudolo, Janet Blodgett. In vitro effects of Ginkgo biloba extract on collagen-induced aggregation and thromboxane B2 synthesis in platelets from type 2 diabetic subjects. International Scientific Conference on Complementary, Alternative & Integrative Medicine Research, April 12-14, 2002. (Journal Of Herbal Pharmacotherapy 3: 5. 2003)
George B. Kudolo, Janet Blodgett. Effect of Ginkgo biloba ingestion on arachidonic acid metabolism in the platelets of type 2 diabetic subjects. International Scientific Conference on Complementary, Alternative & Integrative Medicine Research, April 12-14, 2002. (Journal Of Herbal Pharmacotherapy 3: 5. 2003)
Wen Wang, Jessica Barrientos, Ryan Elrod, Ken Cusi, Janet Blodgett, George B. Kudolo. Effect of Ginkgo biloba extract on platelet aggregation, thromboxane B2 production and leg blood flow in healthy subjects. First International Conference on Whole Person Healing Conference. Washington, DC, March 28-30, 2003.
Kudolo GB, Wang W, Barrientos J, Elrod R, Blodgett J. The ingestion of Ginkgo biloba extract (EGb 761) inhibits arachidonic acid-mediated platelet aggregation and thromboxane B2 production in healthy volunteers. J Herb Pharmacother. 2004;4(4):13-26.
Kudolo GB, Dorsey S, Blodgett J. Effect of the ingestion of Ginkgo biloba extract on platelet aggregation and urinary prostanoid excretion in healthy and Type 2 diabetic subjects. Thromb Res. 2002 Nov 1;108(2-3):151-60.
Kudolo GB, Wang W, Dorsey S, Blodgett J. Oral ingestion of Ginkgo biloba extract reduces thiobarbituric acid reacting (TBAR) substances in washed platelets of healthy subjects. J Herb Pharmacother. 2003;3(4):1-15.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

May 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of type 2 diabetes mellitus and taking oral diabetes medications - Glucotrol, Glucophage and Actose or Avandia
Must be able to swallow
Healthy individuals without diabetes aged 20 to 80 years of age

Exclusion Criteria:

Type 1 diabetes mellitus
Type 2 diabetes mellitus taking insulin injections
Regular use of anti-inflammatory drugs
Chronic anemia

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00032474

Other Study ID Numbers ^ICMJE

R01 AT000832-01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

George B. Kudolo, PhD

University of Texas Health Science Center at San Antonio

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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