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Home > "G" Clinical Trials Conditions > Ginkgo Biloba Extract and the Insulin Resistance Syndrome  Ginkgo Biloba Extract and the Insulin Resistance Syndrome
Ginkgo Biloba Extract and the Insulin Resistance Syndrome
For Condition: Type 2 diabetes mellitus
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: 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.
Details: 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 significantly increases pancreatic beta-cell function. The increased plasma C-peptide levels in response to glucose loading is accompanied by decreased plasma insulin levels and no significant changes in plasma glucose levels. The central hypothesis of this application is that ingestion of Ginkgo biloba produces the dissimilar plasma C-peptide/insulin ratios by increasing the metabolic clearance rates of insulin and the antidiabetic medications. The underlying mechanism may involve the alteration of drug pharmacokinetics resulting in decreased efficacy of the hypoglycemic agents and increased whole body insulin resistance. The primary objective of this study is to determine the mechanism by which Ginkgo biloba may accelerate pancreatic function and reduce glucose metabolism. The specific aims of this project are to determine (a) the effect of ingesting Ginkgo biloba on the pharmacokinetics of glipizide, pioglitazone and metformin and (b) how the interaction between Ginkgo biloba and the three hypoglycemic agents affect the three homeostatic variables that control blood glucose levels: insulin synthesis, insulin action and hepatic glucose production. 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, when taken together should provide very important information on balancing the risk of accelerating pancreatic beta-cell dysfunction, with its beneficial effects on delaying the onset of cognitive function. The results of this study should also provide valuable information for designing new therapeutic strategies for the treatment of diseases in the insulin resistance syndrome.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Minimum Age/Maximum Age: 20 Years/80 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
GeorgeKudolo, Principal Investigator, University of Texas
University of Texas Health Sciences Center *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting
Additional Information:
Study ID Numbers: 1 R01 AT00832-01;
Study Start Date: December 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032474
Other Type 2 Diabetes Mellitus Studies:
1. Ginkgo Biloba Extract and the Insulin Resistance Syndrome
2. Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
3. Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin
Related Studies:
Other Type 2 diabetes mellitus Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Ginkgo Biloba Extract and the Insulin Resistance Syndrome
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