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

May 22, 2023 updated by: Karina Griselda Pérez Rubio, University of Guadalajara

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Metformin
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
Drug: Metformin
The intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks.
Other Names:
  • Brad Predial
Experimental: Dihydromyricetin
Dihydromyricetin capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
Drug: Dihydromyricetin
The intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks.
Other Names:
  • Ampelopsis grossedentata Extract

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting glucose
Time Frame: Baseline to Week 12
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
Postprandial glucose
Time Frame: Baseline to Week 12
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
Glycosylated hemoglobin
Time Frame: Baseline to Week 12
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
Insulin sensitivity
Time Frame: Baseline to Week 12
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
Total insulin secretion
Time Frame: Baseline to Week 12
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
First phase of insulin secretion
Time Frame: Baseline to Week 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Triglycerides levels
Time Frame: Baseline to Week 12
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
Creatinine levels
Time Frame: Baseline to Week 12
Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Baseline to Week 12
Waist Circumference
Time Frame: Baseline to Week 12
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape.
Baseline to Week 12
Body Weigh
Time Frame: Baseline, week 4, week 8 and week 12
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
Body Mass Index
Time Frame: Baseline, week 4, week 8 and week 12
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
C reactive protein
Time Frame: Baseline to Week 12
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
Interleukin 6
Time Frame: Baseline to Week 12
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
Total Cholesterol
Time Frame: Baseline to Week 12
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
High Density Lipoprotein (c-HDL) levels
Time Frame: Basline to Week 12
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
Low Density Lipoproteins (c-LDL) levels
Time Frame: Baseline to Week 12
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
Alanine aminotransferase (ALT) levels
Time Frame: Baseline to Week 12
ALT levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Baseline to Week 12
Aspartate aminotransferase (AST) levels
Time Frame: Baseline to Week 12
AST levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Baseline to Week 12
Blood pressure
Time Frame: Baseline to Week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Guadalajara

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MANUEL GONZALEZ ORTIZ, PhD, Instituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DHM-Metformin-T2DM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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