Clinical trial NCT03606694: Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus
Official title: Effect of Dihydromirycetin Administration on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: dihydromyricetin
metformin
type 2 diabetes mellitus
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fasting glucose
timeFrame: Baseline to Week 12
measure: Postprandial glucose
timeFrame: Baseline to Week 12
measure: Glycosylated hemoglobin
timeFrame: Baseline to Week 12
measure: Insulin sensitivity
timeFrame: Baseline to Week 12
measure: Total insulin secretion
timeFrame: Baseline to Week 12
measure: First phase of insulin secretion
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Waist Circumference
timeFrame: Baseline to Week 12
measure: Body Weigh
timeFrame: Baseline, week 4, week 8 and week 12
measure: Body Mass Index
timeFrame: Baseline, week 4, week 8 and week 12
measure: C reactive protein
timeFrame: Baseline to Week 12
measure: Interleukin 6
timeFrame: Baseline to Week 12
measure: Total Cholesterol
timeFrame: Baseline to Week 12
measure: Triglycerides levels
timeFrame: Baseline to Week 12
measure: High Density Lipoprotein (c-HDL) levels
timeFrame: Basline to Week 12
measure: Low Density Lipoproteins (c-LDL) levels
timeFrame: Baseline to Week 12
measure: Creatinine levels
timeFrame: Baseline to Week 12
measure: Alanine aminotransferase (ALT) levels
timeFrame: Baseline to Week 12
measure: Aspartate aminotransferase (AST) levels
timeFrame: Baseline to Week 12
measure: Blood pressure
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: Instituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara
name: MANUEL GONZALEZ ORTIZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: