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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03606694
• Other study ID #: DHM-Metformin-T2DM
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 30, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 30, 2023
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dihydromyricetin
The intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks.
• Metformin
The intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks.

Locations

Country	Name	City	State
Mexico	Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	Changes in fasting glucose levels after 12 weeks of intervention with dihydromyricetin and metformin. The fasting glucose levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12.	Baseline to Week 12
Primary	Postprandial glucose	Changes in postprandial glucose levels after 12 weeks of intervention with dihydromyricetin and metformin. Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12.	Baseline to Week 12
Primary	Glycosylated hemoglobin	Changes in glycosylated hemoglobin (A1C) after 12 weeks of intervention with dihydromyricetin and metformin. Glycosylated hemoglobin will be evaluated at baseline and week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12.	Baseline to Week 12
Primary	Insulin sensitivity	Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12.	Baseline to Week 12
Primary	Total insulin secretion	Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12.	Baseline to Week 12
Primary	First phase of insulin secretion	The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12.	Baseline to Week 12
Secondary	Waist Circumference	Waist circumference will be evaluated at baseline and at week 12 with a flexible tape.	Baseline to Week 12
Secondary	Body Weigh	The body weight will be measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12.	Baseline, week 4, week 8 and week 12
Secondary	Body Mass Index	Body Mas Index will be calculated at baseline, week 4, week 8 and week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12.	Baseline, week 4, week 8 and week 12
Secondary	C reactive protein	C reactive protein will be evaluated at baseline and week 12 by enzyme-linked immunosorbent assay (ELISA) and the entered values reflect the creatinine levels at week 12	Baseline to Week 12
Secondary	Interleukin 6	Interleukin 6 will be evaluated at the beginning and during week 12 using the enzyme-linked immunosorbent assay (ELISA) and the values entered reflect creatinine levels at week 12	Baseline to Week 12
Secondary	Total Cholesterol	Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12	Baseline to Week 12
Secondary	Triglycerides levels	Triglycerides levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12	Baseline to Week 12
Secondary	High Density Lipoprotein (c-HDL) levels	c-HDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12	Basline to Week 12
Secondary	Low Density Lipoproteins (c-LDL) levels	c-LDL levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12	Baseline to Week 12
Secondary	Creatinine levels	Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques	Baseline to Week 12
Secondary	Alanine aminotransferase (ALT) levels	ALT levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques	Baseline to Week 12
Secondary	Aspartate aminotransferase (AST) levels	AST levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques	Baseline to Week 12
Secondary	Blood pressure	Blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12	Baseline to Week 12