Ginkgo Biloba Extract and the Insulin Resistance Syndrome - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00032474

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Ginkgo biloba extract	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Ginkgo Biloba Extract and the Insulin Resistance Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Metabolic Syndrome

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	150
Study Start Date:	December 2001
Estimated Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032474

Locations

United States, Texas
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

George B. Kudolo, PhD

University of Texas

More Information

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.

ClinicalTrials.gov Identifier:	NCT00032474 History of Changes
Other Study ID Numbers:	R01 AT000832-01
Study First Received:	March 21, 2002
Last Updated:	August 17, 2006
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Ginkgo biloba
type 2 diabetes
platelet function
antioxidant

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Metabolic Syndrome X

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on February 12, 2012