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

NCT03606694 | Unknown Phase 2

• 1 other identifier: DHM-Metformin-T2DM
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

dihydromyricetin; metformin; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (13)

• Waist Circumference

  Baseline to Week 12

• Body Weigh

  Baseline, week 4, week 8 and week 12

• Body Mass Index

  Baseline, week 4, week 8 and week 12

• C reactive protein

  Baseline to Week 12

• Interleukin 6

  Baseline to Week 12

Study Arms (2)

Dihydromyricetin

EXPERIMENTAL

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

Drug: Dihydromyricetin

Metformin

EXPERIMENTAL

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

Drug: Metformin

Interventions

Dihydromyricetin DRUG

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

Also known as: Ampelopsis grossedentata Extract

Dihydromyricetin

Metformin DRUG

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

Also known as: Brad Predial

Metformin

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dihydromyricetin; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• MANUEL GONZALEZ ORTIZ, PhD

  Instituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Assignment

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: October 30, 2019
• Primary Completion: December 28, 2022
• Study Completion: December 30, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

ME (1)