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Ginkgo Biloba |
Ginkgo; Japanese Silver Apricot; Kew Tree; Maidenhair Tree; Yinhsing |
Clinical Trial: Ginkgo Biloba Extract and the Insulin Resistance Syndrome
This study is no longer recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Type 2 diabetes mellitus | Drug: Ginkgo biloba extract | Phase I Phase II |
MedlinePlus related topics: Diabetes
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Expected Total Enrollment: 150
Study start: December 2001; Study completion: May 2005
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 - 80 Years, Genders Eligible for Study: Both
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
Location Information
Texas
University of Texas Health Sciences Center, San Antonio, Texas, 78229, United States
George B. Kudolo, PhD, Principal Investigator, 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, 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.
Record last reviewed: October 2004
Last Updated: October 20, 2004
Record first received: March 21, 2002
ClinicalTrials.gov Identifier: NCT00032474
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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