Ginkgo Biloba Extract and the Insulin Resistance Syndrome
Information source: National Center for Complementary and Alternative Medicine (NCCAM)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Ginkgo biloba extract (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM) Official(s) and/or principal investigator(s):
George B. Kudolo, PhD, Principal Investigator, Affiliation: University of Texas
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.
Clinical Details
Official title: Ginkgo Biloba Extract and the Insulin Resistance Syndrome
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
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
Minimum age: 20 Years.
Maximum age: 80 Years.
Gender(s): 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
Locations and Contacts
University of Texas Health Sciences Center, San Antonio, Texas 78229, United States
Additional Information
Related 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.
Starting date: December 2001
Ending date: May 2005
Last updated: August 17, 2006
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