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

NCT ID: NCT03606694

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2023-12-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dihydromyricetin

Dihydromyricetin capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.

Group Type: EXPERIMENTAL

Dihydromyricetin

Intervention Type: DRUG

The intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks.

Metformin

Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

The intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks.

Interventions

Dihydromyricetin

The intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks.

Intervention Type: DRUG

Metformin

The intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Ampelopsis grossedentata Extract; Brad Predial

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Karina Griselda Pérez Rubio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MANUEL GONZALEZ ORTIZ, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara

Locations

Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Countries

Mexico

Other Identifiers

DHM-Metformin-T2DM

Identifier Type: -

Identifier Source: org_study_id