Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus

University of Guadalajara

Status and phase

Active, not recruiting

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Dihydromyricetin

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT03606694

DHM-Metformin-T2DM

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients both sexes
Age between 30 and 60 years
Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dL; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl; or glycosylated hemoglobin between >6.5%)
Informed consent signed

Exclusion criteria

Women with confirmed or suspected pregnancy, or under lactation and/or puerperium
Previous treatment for glucose
Fasting glucose ≥250 mg/dL
Body Mass Index ≥34.9 kg/m2
Known uncontrolled renal, hepatic, heart or thyroid diseased
Hypersensibility to ingredients of intervention
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Blood Pressure ≥140/90 mmHg