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Ginkgo Biloba Extract and the Insulin Resistance Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00032474
First Posted: March 22, 2002
Last Update Posted: August 18, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Ginkgo Biloba Extract and the Insulin Resistance Syndrome

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Integrative Health (NCCIH)
Investigators
Principal Investigator: George B. Kudolo, PhD The University of Texas Health Science Center at San Antonio
  More Information

Publications:
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.

ClinicalTrials.gov Identifier: NCT00032474     History of Changes
Other Study ID Numbers: R01AT000832-01 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2002
First Posted: March 22, 2002
Last Update Posted: August 18, 2006
Last Verified: July 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
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