Type 2 Diabetes MellitusPhase 2NCT03606694
Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus
A Phase 2 study testing Dihydromyricetin and Metformin in people with Type 2 Diabetes Mellitus, run by University of Guadalajara at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Dihydromyricetin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 30 Oct 2019to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Triglycerides ≥500 mg/dL
- Total cholesterol ≥240 mg/dL
- Blood Pressure ≥140/90 mmHg
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: 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.
Read the 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
- Being tested
- Dihydromyricetin, Metformin
- Keywords
- dihydromyricetin, metformin, type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydromyricetinDrug
Also called Ampelopsis grossedentata Extract
The intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks.
MetforminDrug
Also called Brad Predial
The intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dihydromyricetin | Experimental | Dihydromyricetin capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. Receives: Drug: Dihydromyricetin |
| Metformin | Experimental | Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Secondary outcomes (13)
Waist Circumference
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape.
Measured: Baseline to Week 12
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.
Measured: Baseline, week 4, week 8 and week 12
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.
Measured: Baseline, week 4, week 8 and week 12
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
Measured: Baseline to Week 12
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
Measured: Baseline to Week 12
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
Measured: Baseline to Week 12
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
Measured: Baseline to Week 12
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
Measured: Basline to Week 12
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
Measured: Baseline to Week 12
Creatinine levels
Creatinine levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Measured: Baseline to Week 12
Alanine aminotransferase (ALT) levels
ALT levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Measured: Baseline to Week 12
Aspartate aminotransferase (AST) levels
AST levels will be evaluated at baseline and week 12 with enzymatic/colorimetric techniques
Measured: Baseline to Week 12
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
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start30 Oct 2019
- Primary completion28 Dec 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina Griselda Pérez Rubio, University of Guadalajara
- Investigators
- MANUEL GONZALEZ ORTIZ, PhD, Principal investigator, Instituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606694
- Sponsor's protocol ID
- DHM-Metformin-T2DM
- Status last verified
- May 2023
- First submitted
- 20 Jul 2018
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dihydromirycetin Administration on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03606694
- Acronym / sponsor ID
- DHM-Metformin-T2DM
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- dihydromyricetin, metformin, type 2 diabetes mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Dihydromyricetin | Experimental | Drug: DihydromyricetinDihydromyricetin capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. |
| Metformin | Experimental | Drug: MetforminMetformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DihydromyricetinAlso: Ampelopsis grossedentata ExtractThe intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks. | Drug | Dihydromyricetin |
| MetforminAlso: Brad PredialThe intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks. | Drug | Metformin |
Primary outcome
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.
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.
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.
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.
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.
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.
13 secondary outcomes
Waist Circumference
Time frame: Baseline to Week 12
Body Weigh
Time frame: Baseline, week 4, week 8 and week 12
Body Mass Index
Time frame: Baseline, week 4, week 8 and week 12
C reactive protein
Time frame: Baseline to Week 12
Interleukin 6
Time frame: Baseline to Week 12
Total Cholesterol
Time frame: Baseline to Week 12
Triglycerides levels
Time frame: Baseline to Week 12
High Density Lipoprotein (c-HDL) levels
Time frame: Basline to Week 12
Low Density Lipoproteins (c-LDL) levels
Time frame: Baseline to Week 12
Creatinine levels
Time frame: Baseline to Week 12
Alanine aminotransferase (ALT) levels
Time frame: Baseline to Week 12
Aspartate aminotransferase (AST) levels
Time frame: Baseline to Week 12
Blood pressure
Time frame: Baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANUEL GONZALEZ ORTIZ, PhD principal investigator
Instituto de Terapeútica Experimental y Clínica. Universidad de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dihydromyricetin and Metformin in people with Type 2 Diabetes Mellitus, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: Baseline to Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.