PreDiabetesPhase 2NCT04341571
Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.
A Phase 2 study testing Probiotics and Metformin in people with PreDiabetes and Impaired Glucose Tolerance, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 31 to 60 years
- Conditions the study is for
- PreDiabetes, Impaired Glucose Tolerance, Hyperglycemia
- What is being tested?
- Probiotics and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 24 Oct 2019to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 ADA criteria (fasting blood glucose levels between 100-125 mg/dL, postprandial blood glucose levels after an oral glucose tolerance test with 75 g of oral glucose between 140-199 mg/dL and glycated hemoglobin between 5.7-6.4 %)
- Body Mass Index from 25 to 34.9 kg/m2
- Stable weight at least the previous last 3 months (weight variation less than 10%)
- Acceptance and signing of informed consent
Who cannot join
- History of kidney, liver or heart disease
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Physical impossibility for taking pills
- Hypersensibility to ingredients of intervention
- Consumption of medications or supplements with effects on glucose levels
Show all 11Show fewer
- Systolic blood pressure ≥ 140 mmHg
- Diastolic blood pressure ≥ 90 mmHg
- HbA1c ≥6.5%
- Triglycerides ≥ 400 mg/dL
- Total cholesterol ≥ 240 mg/dL
Trial locations and contacts
1 site in 1 country.
Mexico1 site
INSTITUTO DE TERAPÉUTICA EXPERIMENTAL Y CLÍNICA. Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of the Administration of Probiotics 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 blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM).
The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM.
Read more
Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment.
The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.
Read the detailed description
A randomized, double-blind controlled clinical trial in 30 patients between 31 to 60 years of age with a diagnosis of prediabetes (IFG 100 a 125 mg/dL, IGT 140 a 199 mg/dL, HbA1c 5.7 a 6.4%) in accordance with the American Diabetes Association without treatment.
Patients with one or more of the following criteria will be excluded: History of liver, kidney or heart disease; systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, HbA1c ≥6.5%, triglycerides ≥ 400 mg/dL, total cholesterol ≥240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on glucose levels.
They will be assigned randomly two groups of 15 patients; one of the groups will receive 750 mg of metformin twice at day (before breakfast and dinner) for 13 weeks.
The other group will receive 400 mg of probiotics 1 time at day (before breakfast) and placebo pill (before dinner) for 13 weeks.
They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated area under curve of glucose an 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. Will be used Wilcoxon range test for identification of differences between baseline and final evaluation of each intervention group, Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered satitistical significance p >0.05.
- Being tested
- Probiotics, Metformin
- Keywords
- Probiotics, Prediabetes, Hyperglycemia, Impaired Fasting Glucose, Glucose intolerance, Metformin
- Medical subject headings
- Prediabetic State, Glucose Intolerance, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Probiotics capsules (lactobacillus acidophilus y bifidobacterium lactis) 400 mg 1 time at day before breakfast and one placebo capsule before dinner during 13 weeks. Homologated to the other intervention.
MetforminDrug
Metformin capsules, 750 mg, two pere day before breakfast and dinner during 13 weeks.
Homologated to the other intervention.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | 15 patients to receive homologated intervention capsule (probiotics lactobacillus acidophilus y bifidobacterium lactis 400 mg) 1 time at day before breakfast along 13 weeks and receive 1 homologated placebo capsule (calcinated magnesia 500 mg) 1 time at day before dinner along 13 weeks. Receives: Dietary Supplement: Probiotics |
| Metformin | Experimental | 15 patients to receive homologated intervention capsule (metformin 750 mg) twice at day before breakfast and dinner for 13 weeks. 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 13 by enzymatic- colorimetric technique to get fasting glucose level
Measured: Baseline to week 13 (end of intervention)
Postpandrial glucose levels
Glucose will be evaluated at baseline and week 13 after a oral glucose tolerance test with enzymatic-colorimetric technique
Measured: Baseline to week 13 (end of intervention)
Glycosylated hemoglobin
Glycosylated hemoglobin will be evaluated at baseline and week 13 by high efficiency liquid chromatography.
Measured: Baseline to week 13 (end of intervention)
Insulin sensitivity
Insulin sensitivity will be calculated at baseline and week 13 with Matsuda index to get insuline sensitivity
Measured: Baseline to week 13 (end of intervention)
Total insulin secretion
Total insulin secretion will be calculated at baseline and week 13 with Insulinogenic index to get total insulin secretion
Measured: Baseline to week 13 (end of intervention)
First phase of insuline secretion
The first phase if insuline secretion will be calculated at baseline and week 13 with Stumvoll index to get first phase of insuline secretion
Measured: Baseline to week 13 (end of intervention)
Secondary outcomes (13)
Body weight
Body weight will be measured at baseline and week 13 with a bioimpedance balance
Measured: Baseline to week 13 (end of intervention)
Body mass index (BMI)
Body mass index will be calculated at baseline and week 13 with the Quetelet index formula
Measured: Baseline to week 13 (end of intervention)
Waist circunference
Waist circunference will be evaluated at baseline and week 13 by World Health Organization technique
Measured: Baseline to week 13 (end of intervention)
Blood pressure
Systolic blood pressure and diastolyc blood pressure will be measured at baseline and week 13 with a digital sphygmomanometer three times in each arm to get an average
Measured: Baseline to week 13 (end of intervention)
Total cholesterol
Total chilesterol level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get total cholesterol level
Measured: Baseline to week 13 (end of intervention)
High density lipoprotein (c-HDL)
High density lipoprotein (c-HDL) level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get c-HDL level
Measured: Baseline to week 13 (end of intervention)
Low density lipoprotein (c-LDL)
Low density lipoprotein (c-LDL) level will be calculated at baseline and week 13 with Friedewald formula to get c-LDL level
Measured: Baseline to week 13 (end of intervention)
Very low density lipoprotein (VLDL)
Very low density lipoprotein (VLDL) level will be calculated at baseline and week 13 with triglycerides concentration/5 formula to get VLDL level
Measured: Baseline to week 13 (end of intervention)
Fasting blood triglycerides concentration
Fasting blood triglycerides concentration level will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get triglycerides concentration
Measured: Baseline to week 13 (end of intervention)
Concentration of blood creatinine
Concentration of blood creatinine level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get creatinine level
Measured: Baseline to week 13 (end of intervention)
Concentration of blood alanine aminostranferase (ALT)
Concentration of blood alanine aminostranferase level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get ALT level
Measured: Baseline to week 13 (end of intervention)
Concentration of blood aspartate aminostranferase (AST)
Concentration of blood aspartate aminostranferase level will be evaluated at baseline and week 13 by enzymatic-colorimetric technique to get AST level
Measured: Baseline to week 13 (end of intervention)
Incidence of treatment-Emergent Adverse Events
Incidence of treatment-Emergent Adverse Events of probiotics+placebo or metformin will be identified by clinical evaluation from baseline week to week 13 with continuous surveiilance
Measured: Baseline to week 13 (continuous surveiilance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start24 Oct 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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 G PÉREZ-RUBIO, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341571
- Sponsor's protocol ID
- Probiotics-Prediabetes
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Patients With Prediabetes.
- ClinicalTrials.gov ID
- NCT04341571
- Acronym / sponsor ID
- Probiotics-Prediabetes
- Keywords
- Probiotics, Prediabetes, Hyperglycemia, Impaired Fasting Glucose, Glucose intolerance, Metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Apr 2020 (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.
Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM).
The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM.
Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment.
The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.
Detailed description
A randomized, double-blind controlled clinical trial in 30 patients between 31 to 60 years of age with a diagnosis of prediabetes (IFG 100 a 125 mg/dL, IGT 140 a 199 mg/dL, HbA1c 5.7 a 6.4%) in accordance with the American Diabetes Association without treatment.
Patients with one or more of the following criteria will be excluded: History of liver, kidney or heart disease; systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, HbA1c ≥6.5%, triglycerides ≥ 400 mg/dL, total cholesterol ≥240 mg/dL; pregnancy or lactation; consumption of medications or supplements with effects on glucose levels.
They will be assigned randomly two groups of 15 patients; one of the groups will receive 750 mg of metformin twice at day (before breakfast and dinner) for 13 weeks.
The other group will receive 400 mg of probiotics 1 time at day (before breakfast) and placebo pill (before dinner) for 13 weeks.
They will be measured fasting blood glucose, postprandial glucose levels and glycosylated hemoglobin, and will be calculated area under curve of glucose an 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. Will be used Wilcoxon range test for identification of differences between baseline and final evaluation of each intervention group, Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered satitistical 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
- Double-blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotics15 patients to receive homologated intervention capsule (probiotics lactobacillus acidophilus y bifidobacterium lactis 400 mg) 1 time at day before breakfast along 13 weeks and receive 1 homologated placebo capsule (calcinated magnesia 500 mg) 1 time at day before dinner along 13 weeks. |
| Metformin | Experimental | Drug: Metformin15 patients to receive homologated intervention capsule (metformin 750 mg) twice at day before breakfast and dinner for 13 weeks. |
Who may qualify
- Ages
- 31 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients both sexes
- Age between 31 and 60 years
- Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-125 mg/dL, postprandial blood glucose levels after an oral glucose tolerance test with 75 g of oral glucose between 140-199 mg/dL and glycated hemoglobin between 5.7-6.4 %)
- Body Mass Index from 25 to 34.9 kg/m2
- Stable weight at least the previous last 3 months (weight variation less than 10%)
Key exclusion criteria (11 listed)
- History of kidney, liver or heart disease
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Physical impossibility for taking pills
- Hypersensibility to ingredients of intervention
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 |
|---|---|---|
| ProbioticsProbiotics capsules (lactobacillus acidophilus y bifidobacterium lactis) 400 mg 1 time at day before breakfast and one placebo capsule before dinner during 13 weeks. Homologated to the other intervention. | Dietary supplement | Probiotics |
| MetforminMetformin capsules, 750 mg, two pere day before breakfast and dinner during 13 weeks. Homologated to the other intervention. | Drug | Metformin |
Primary outcome
Fasting glucose levels
Time frame: Baseline to week 13 (end of intervention)
The fasting glucose levels will be evaluated at baseline and week 13 by enzymatic- colorimetric technique to get fasting glucose level
Postpandrial glucose levels
Time frame: Baseline to week 13 (end of intervention)
Glucose will be evaluated at baseline and week 13 after a oral glucose tolerance test with enzymatic-colorimetric technique
Glycosylated hemoglobin
Time frame: Baseline to week 13 (end of intervention)
Glycosylated hemoglobin will be evaluated at baseline and week 13 by high efficiency liquid chromatography.
Insulin sensitivity
Time frame: Baseline to week 13 (end of intervention)
Insulin sensitivity will be calculated at baseline and week 13 with Matsuda index to get insuline sensitivity
Total insulin secretion
Time frame: Baseline to week 13 (end of intervention)
Total insulin secretion will be calculated at baseline and week 13 with Insulinogenic index to get total insulin secretion
First phase of insuline secretion
Time frame: Baseline to week 13 (end of intervention)
The first phase if insuline secretion will be calculated at baseline and week 13 with Stumvoll index to get first phase of insuline secretion
13 secondary outcomes
Body weight
Time frame: Baseline to week 13 (end of intervention)
Body mass index (BMI)
Time frame: Baseline to week 13 (end of intervention)
Waist circunference
Time frame: Baseline to week 13 (end of intervention)
Blood pressure
Time frame: Baseline to week 13 (end of intervention)
Total cholesterol
Time frame: Baseline to week 13 (end of intervention)
High density lipoprotein (c-HDL)
Time frame: Baseline to week 13 (end of intervention)
Low density lipoprotein (c-LDL)
Time frame: Baseline to week 13 (end of intervention)
Very low density lipoprotein (VLDL)
Time frame: Baseline to week 13 (end of intervention)
Fasting blood triglycerides concentration
Time frame: Baseline to week 13 (end of intervention)
Concentration of blood creatinine
Time frame: Baseline to week 13 (end of intervention)
Concentration of blood alanine aminostranferase (ALT)
Time frame: Baseline to week 13 (end of intervention)
Concentration of blood aspartate aminostranferase (AST)
Time frame: Baseline to week 13 (end of intervention)
Incidence of treatment-Emergent Adverse Events
Time frame: Baseline to week 13 (continuous surveiilance)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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 G PÉREZ-RUBIO, 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 2 study testing Probiotics and Metformin in people with PreDiabetes and Impaired Glucose Tolerance, 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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 13 (end of intervention)). 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 7 Oct 2026.