Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05081583
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2021-10-04
Brief Title:
Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients
Sponsor:
Washington State University
Organization:
Washington State University
Study Overview
Official Title:
Clinical Evaluation of the Pharmacokinetic Goldenseal-Metformin Interaction in Diabetic Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Supplements containing goldenseal a perennial herb native to North America have consistently ranked among the top 20 highest selling natural products throughout the last decade Goldenseal products are marketed as licensed natural health products in Canada and as dietary supplements in the United States Natural products made from dried roots of the goldenseal plant are purported to have therapeutic value and are used to self-treat a range of medical complications including the common cold allergic rhinitis and digestive disorders such as diarrhea and constipation Based on a previous clinical study goldenseal have been shown to precipitate pharmacokinetic interactions with metformin in healthy volunteers This follow-up study aims to evaluate the goldenseal-metformin interaction in type 2 diabetic patients Results from this proposed clinical study will 1 characterize the pharmacokinetic interaction between the botanical dietary supplement goldenseal and anti-diabetic drug metformin 2 provide evidence-based recommendations to mitigate drug interaction risks and 3 contribute to the development of a comprehensive strategy for effectively assessing other potential natural-product drug interactions
Detailed Description:
Many patient groups including those afflicted with cardiovascular disease cancer HIVAIDS hepatitis C and diabetes often supplement their prescribed pharmacotherapeutic regimens with herbal and other natural products raising concern for adverse interactions Unlike for drug-drug interactions rigorous harmonized guidelines for assessing the risk of natural product-drug interactions do not exist The NCCIH-funded Center of Excellence for Natural Product Drug Interaction NaPDI Research was established in September 2015 The mission of the NaPDI Center is to provide leadership in the identification evaluation and dissemination of potential clinically meaningful pharmacokinetic natural product-drug interactions Goldenseal is one of four high priority natural products selected by the NaPDI Center for further evaluation for drug interaction potential
A recent clinical study completed by researchers at the NaPDI center showed that a well-characterized adulterant- and contaminant-free goldenseal product administered to 16 healthy volunteers 3 g daily by mouth for 6 consecutive days resulted in a significant decrease 23 in metformin systemic exposure area under the plasma concentration-time curve AUC with no change in half-life or renal clearance Based on these clinical observations along with complementary in vitro data the current working hypothesis is that goldenseal interacts with intestinal organic cation transporter 1 to alter metformin disposition These observations may have clinical implications for diabetic patients as metformin is the first-line treatment and most prescribed anti-diabetic medication for type 2 diabetes The objective of this study is to assess the potential for goldenseal to alter the pharmacokinetics and clinical effects of standard metformin treatment in well-controlled adult type 2 diabetic patients
Transporter inhibition represents an understudied mechanism of natural product-drug interactions The proposed clinical study will be the first of its kind to evaluate whether such pharmacokinetic interactions can potentially affect clinical outcomes The knowledge gained from these efforts will ultimately build upon a systematic framework for effectively studying other transporter-mediated natural product-drug interactions
A recent clinical study completed by researchers at the NaPDI center showed that a well-characterized adulterant- and contaminant-free goldenseal product administered to 16 healthy volunteers 3 g daily by mouth for 6 consecutive days resulted in a significant decrease 23 in metformin systemic exposure area under the plasma concentration-time curve AUC with no change in half-life or renal clearance Based on these clinical observations along with complementary in vitro data the current working hypothesis is that goldenseal interacts with intestinal organic cation transporter 1 to alter metformin disposition These observations may have clinical implications for diabetic patients as metformin is the first-line treatment and most prescribed anti-diabetic medication for type 2 diabetes The objective of this study is to assess the potential for goldenseal to alter the pharmacokinetics and clinical effects of standard metformin treatment in well-controlled adult type 2 diabetic patients
Transporter inhibition represents an understudied mechanism of natural product-drug interactions The proposed clinical study will be the first of its kind to evaluate whether such pharmacokinetic interactions can potentially affect clinical outcomes The knowledge gained from these efforts will ultimately build upon a systematic framework for effectively studying other transporter-mediated natural product-drug interactions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54AT008909 | NIH | None | httpsreporternihgovquickSearchU54AT008909 |