Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT03606694
Status:
UNKNOWN
Last Update Posted:
2023-05-23
First Post:
2018-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus
Sponsor:
University of Guadalajara
Organization:
Study Overview
Official Title:
Effect of Dihydromirycetin Administration on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Dihydromyricetin has demonstrated promising effects in glycemic control, insulin sensitivity and insulin secretion, that above mentioned findings show that dihydromyricetin has an excellent potential effect in the treatment of type 2 diabetes mellitus patients.
Detailed Description:
A double-blind, randomized clinical trial of three pharmacological groups in 36 patients with a diagnosis of type 2 diabetes mellitus in accordance with the American Diabetes Association (ADA) without treatment.
They will be assigned randomly two groups of 12 patients, each one will receive dihydromyricetin 300 mg or metformin 850 mg, two times per day before having break-fast and before having dinner during 12 weeks.
The Area Under the Curve of glucose and insulin will be calculated, total insulin secretion (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
They will be assigned randomly two groups of 12 patients, each one will receive dihydromyricetin 300 mg or metformin 850 mg, two times per day before having break-fast and before having dinner during 12 weeks.
The Area Under the Curve of glucose and insulin will be calculated, total insulin secretion (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: