PrediabetesPhase 4NCT03029390
Effect of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes
A Phase 4 study testing Berberine and Metformin in people with Prediabetes and Impaired Fasting Glucose, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher risk to develop type 2 diabetes mellitus (T2DM) in 10 years. Read more about this study
- Who is it for?
- Ages 31 to 60 years
- Conditions the study is for
- Prediabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance
- What is being tested?
- Berberine and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2016to Dec 2023
- Phase
- Phase 4
- 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 31 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients both sexes
- Age between 31 and 60 years
- Diagnosis of prediabetes according 2 ADA criteria (fasting blood glucose levels between 100-125 mg/dl and postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl)
- Body Mass Index from 25 to 34.9kg/m2
- Informed consent signed
Who cannot join
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to ingredients of intervention
- Physical impossibility for taking pills
- Known uncontrolled renal, hepatic, heart or thyroid diseased
- Diabetes diagnosis
Show all 13Show fewer
- Previous treatment for glucose
- Body Mass Index ≥35 kg/m2
- Glycosylated hemoglobin > 6.5%
- Triglycerides ≥500 mg/dL
- Total cholesterol ≥240 mg/dL
- Low density lipoprotein (c-LDL) ≥190 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 Administration of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes
Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher risk to develop type 2 diabetes mellitus (T2DM) in 10 years.
The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, the traditional Chinese and Ayurverica medicine offer potential active substances for the treatment of hyperglucemia like berberine.
Read more
Berberine is an extract with hypoglycemic effects in animal models as well as in clinical trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's activity against metformin in prediabetes would provide impact information on a new alternative treatment and compare with the standard pharmacological treatment.
The aim of the study evaluate the effect of administration of berberine versus metaformine on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.
The investigators hypothesis is that the administration of berberine versus metformin modifies glycemic control, insulin sensitivity and insulin secretion in patients with prediabetes.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial in 28 patients with a diagnosis of prediabetes (IFG and IGT) in accordance with the American Diabetes Association with out treatment.
They will be assigned randomly two groups of 14 patients, one of the groups will receive 850 mg of metformin twice at day (before breakfast and before dinner) and one pill of placebo (before lunch) for 14 weeks. There will be a running period, starting with a dose of 500 mg the first week, the second week increasing to 1000 mg and from the third to the fourteenth week will be a dose of 1500 mg.
The other group will receive 500 mg of berberine three times at day (each one before the mealtime) for14 weeks. There will be a running period, starting with a dose of 850 mg the first week, the second week dose of 850 mg of metformin plus one placebo pill and from the third week to the fourteenth week will be a dose of 1700 mg ( two 850 mg metformin pills) plus one placebo pill.
They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated Area Under Curve of glucose and insulin, total insulin secretion (Insolinogenic index), first-phase of insulin secretion (Strumvoll index) and insulin sensitivity (Matsuda index).
This protocol it's 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 percentage for qualitative variable. 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.
- Being tested
- Berberine, Metformin
- Keywords
- Prediabetes, hyperglycemia, Impaired Fasting Glucose, Metformin, Berberine, glucose intolerance
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDietary supplement
Also called Berberine hydrochloride
Berberine capsules, 500 mg, three per day before each meal during 14 weeks.
The patients will have a running period during two weeks:
First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study (14 week), they will be receive three 500 mg
MetforminDrug
Metformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 14 weeks.
The patients will have a running period:
First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal).
From the third week until the end of the study (14 week), they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal).
| Study group | Role | What they receive |
|---|---|---|
| Berberine hydrochloride | Experimental | Berberine capsules, 500 mg, three per day before each meal during 12 weeks.
The patients will have a forced titration period:
First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study, they will be receive three 500 mg capsules (before each meal) Receives: Dietary Supplement: Berberine |
| Metformin | Experimental | Metformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 12 weeks.
The patients will have a forced titration period:
First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal).
From the third week until the end of the study, they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal). Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose levels
The fasting glucose levels will be evaluated at baseline and week 14 with enzymatic/ colorimetric techniques and the entered values reflect the fasting glucose level at week 14
Measured: Baseline to week 14
postprandial glucose levels
Postprandial glucose will be evaluated at baseline week 14 after a oral glucose tolerance test with enzymatic/ colorimetric techniques and the entered values reflect the insulin sensitivity at week 14
Measured: baseline to week 14
Glycosylated hemoglobin
Glycosylated hemoglobin will be evaluated at baseline and week 14 by Elisa and the entered values reflect the glycosylated hemoglobin at week 14
Measured: baseline to week 14
Total insulin secretion
Total insulin secretion will be calculated at baseline and week 14 with insulinogenic index and the entered values reflect the total insulin secretion at week 14
Measured: baseline to week 14
First phase of insulin secretion
The first phase of insulin secretion will be calculated at baseline and week 14 with Strumvoll index and the entered values reflect the first phase of insulin secretion at week 14
Measured: baseline to week 14
Insulin sensitivity
Insulin sensitivity will be calculated at baseline and week 14 with Matsuda index and the entered values reflect the insulin sensitivity at week 14
Measured: baseline to week 14
Secondary outcomes (12)
Body Weight
The body weight will be measured at baseline, week 3, week 6, week 10, and week 14 with a bioimpedance balance and the entered values reflect the body weight at week 14
Measured: Baseline to week 14
Body Mass Index
Body Mas Index will be calculated at baseline, week 3, week 6, week 10, and week 14 with the Quetelet index formula and the entered values reflect the body mass index at week 14
Measured: Baseline to week 14
Body fat percentage
Body fat percentage will be evaluated at baseline, week 3, week 6, week 10, and week 14 by Bioimpedance technique and the entered values reflect the body fat percentage at week 14
Measured: Baseline to week 14
Waist circumference
Waist circumference will be evaluated at baseline, week 3, week 6, week 10 and week 14 by World Health Organization technique and the entered values reflect the waist circumference mesure at week 14
Measured: Baseline to week 14
Blood pressure
Blood pressure will be measured at baseline,week 3, week 6, week 10 and week week 14 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 14
Measured: Baseline to week 14
Total cholesterol
Total cholesterol levels will be evaluated at baseline and week 14 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 14
Measured: Baseline to week 14
Triglycerides levels
Triglycerides levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 14
Measured: Baseline to week 14
High density lipoprotein (c-HDL) levels
c-HDL levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 14
Measured: Baseline to week 14
Low density lipoprotein (c-LDL) levels
c-LDL levels will be will be calculated at baseline and week 14 with Friedewald Formula and the entered values reflect the c-HDL level at week 14
Measured: Baseline to week 14
Alanine aminotransferase (ALT) levels
ALT levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques
Measured: Baseline to week 14
Aspartate aminotransferase (AST) levels
AST levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques
Measured: Baseline to week 14
Creatinine levels
Creatinine levels will be evaluated at baseline and week 14 with enzymatic/colorimetric techniques
Measured: Baseline to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- KARINA GRISELDA PEREZ, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029390
- Sponsor's protocol ID
- BM-Prediabetes
- Status last verified
- Jun 2022
- First submitted
- 20 Jan 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- 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 Administration of Berberine Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes
- ClinicalTrials.gov ID
- NCT03029390
- Acronym / sponsor ID
- BM-Prediabetes
- Keywords
- Prediabetes, hyperglycemia, Impaired Fasting Glucose, Metformin, Berberine, glucose intolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
Pre diabetes (PD) is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), Imparied glucose tolerance (IGT) or both, involving a higher risk to develop type 2 diabetes mellitus (T2DM) in 10 years.
The efficacy of pharmacotherapy in the prevention of diabetes in adults with prediabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, the traditional Chinese and Ayurverica medicine offer potential active substances for the treatment of hyperglucemia like berberine.
Berberine is an extract with hypoglycemic effects in animal models as well as in clinical trials in type 2 diabetes mellitus even compared to metformin, for this reason comparing it's activity against metformin in prediabetes would provide impact information on a new alternative treatment and compare with the standard pharmacological treatment.
The aim of the study evaluate the effect of administration of berberine versus metaformine on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.
The investigators hypothesis is that the administration of berberine versus metformin modifies glycemic control, insulin sensitivity and insulin secretion in patients with prediabetes.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial in 28 patients with a diagnosis of prediabetes (IFG and IGT) in accordance with the American Diabetes Association with out treatment.
They will be assigned randomly two groups of 14 patients, one of the groups will receive 850 mg of metformin twice at day (before breakfast and before dinner) and one pill of placebo (before lunch) for 14 weeks. There will be a running period, starting with a dose of 500 mg the first week, the second week increasing to 1000 mg and from the third to the fourteenth week will be a dose of 1500 mg.
The other group will receive 500 mg of berberine three times at day (each one before the mealtime) for14 weeks. There will be a running period, starting with a dose of 850 mg the first week, the second week dose of 850 mg of metformin plus one placebo pill and from the third week to the fourteenth week will be a dose of 1700 mg ( two 850 mg metformin pills) plus one placebo pill.
They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated Area Under Curve of glucose and insulin, total insulin secretion (Insolinogenic index), first-phase of insulin secretion (Strumvoll index) and insulin sensitivity (Matsuda index).
This protocol it's 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 percentage for qualitative variable. 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
| Arm | Type | Receives |
|---|---|---|
| Berberine hydrochloride | Experimental | Dietary Supplement: BerberineBerberine capsules, 500 mg, three per day before each meal during 12 weeks. The patients will have a forced titration period: First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study, they will be receive three 500 mg capsules (before each meal) |
| Metformin | Experimental | Drug: MetforminMetformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 12 weeks. The patients will have a forced titration period: First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal). From the third week until the end of the study, they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal). |
Who may qualify
- Ages
- 31 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients both sexes
- Age between 31 and 60 years
- Diagnosis of prediabetes according 2 ADA criteria (fasting blood glucose levels between 100-125 mg/dl and postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl)
- Body Mass Index from 25 to 34.9kg/m2
- Informed consent signed
Key exclusion criteria (13 listed)
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Hypersensibility to ingredients of intervention
- Physical impossibility for taking pills
- 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 |
|---|---|---|
| BerberineAlso: Berberine hydrochlorideBerberine capsules, 500 mg, three per day before each meal during 14 weeks. The patients will have a running period during two weeks: First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study (14 week), they will be receive three 500 mg | Dietary supplement | Berberine hydrochloride |
| MetforminMetformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 14 weeks. The patients will have a running period: First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal). From the third week until the end of the study (14 week), they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal). | Drug | Metformin |
Primary outcome
Fasting glucose levels
Time frame: Baseline to week 14
The fasting glucose levels will be evaluated at baseline and week 14 with enzymatic/ colorimetric techniques and the entered values reflect the fasting glucose level at week 14
postprandial glucose levels
Time frame: baseline to week 14
Postprandial glucose will be evaluated at baseline week 14 after a oral glucose tolerance test with enzymatic/ colorimetric techniques and the entered values reflect the insulin sensitivity at week 14
Glycosylated hemoglobin
Time frame: baseline to week 14
Glycosylated hemoglobin will be evaluated at baseline and week 14 by Elisa and the entered values reflect the glycosylated hemoglobin at week 14
Total insulin secretion
Time frame: baseline to week 14
Total insulin secretion will be calculated at baseline and week 14 with insulinogenic index and the entered values reflect the total insulin secretion at week 14
First phase of insulin secretion
Time frame: baseline to week 14
The first phase of insulin secretion will be calculated at baseline and week 14 with Strumvoll index and the entered values reflect the first phase of insulin secretion at week 14
Insulin sensitivity
Time frame: baseline to week 14
Insulin sensitivity will be calculated at baseline and week 14 with Matsuda index and the entered values reflect the insulin sensitivity at week 14
12 secondary outcomes
Body Weight
Time frame: Baseline to week 14
Body Mass Index
Time frame: Baseline to week 14
Body fat percentage
Time frame: Baseline to week 14
Waist circumference
Time frame: Baseline to week 14
Blood pressure
Time frame: Baseline to week 14
Total cholesterol
Time frame: Baseline to week 14
Triglycerides levels
Time frame: Baseline to week 14
High density lipoprotein (c-HDL) levels
Time frame: Baseline to week 14
Low density lipoprotein (c-LDL) levels
Time frame: Baseline to week 14
Alanine aminotransferase (ALT) levels
Time frame: Baseline to week 14
Aspartate aminotransferase (AST) levels
Time frame: Baseline to week 14
Creatinine levels
Time frame: Baseline to week 14
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.
KARINA GRISELDA PEREZ, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Berberine and Metformin in people with Prediabetes and Impaired Fasting Glucose, 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 5 inclusion and 13 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 levels (time frame: Baseline to week 14). 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.