Diabetes Mellitus, Type 2Phase 2NCT03416127
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing Propolis and Metformin in people with Diabetes Mellitus, Type 2, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment. All patients received for 12 weeks propolis, metformin or placebo. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Propolis and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jan 2018to 20 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Mild to moderate physical activity
- Stable body weight for at least 12 weeks prior to the study
- BMI 25.0 - 34.9 kg/m2
- Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl
- Informed consent signed
Who cannot join
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Previous treatment for glucose
- Fasting glucose ≥250 mg/dL
- Known uncontrolled renal, hepatic, heart or thyroid diseased
- Hypersensibility to ingredients of intervention
Show all 9Show fewer
- Known allergies to bee stings or their derived products
- Triglycerides ≥500 mg/dL
- Total cholesterol ≥240 mg/dL
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Intstituto 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 Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment
The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment.
All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index, and Matsuda index were measured.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without pharmacological treatment.
At the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas under the curve of glucose and insulin, total insulin secretion insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated.
All patients received for 12 weeks two capsules a day, one before the first bite of breakfast and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12 received metformin (850 mg), and 12 more placebo in the same pharmacological presentation.
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
Results are presented as mean and standard deviation. Intra-group differences were evaluated using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated with the Wilcoxon test; p≤0.05 was considered significant.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Propolis, Metformin, Placebo
- Keywords
- Diabetes Mellitus type 2, Glycemic control, Propolis, Metformin, Pharmacological treatment-naïve patients
- 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.
PropolisDrug
Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
MetforminDrug
Also called Metformin hydrochloride
Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
PlaceboDrug
Also called Calcined magnesium
Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Propolis | Experimental | Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. Receives: Drug: Propolis |
| Metformin | Experimental | Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo capsules, two times per day before break-fast and dinner during 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Serum Glucose
The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Measured: Week 12
2 Hours After Oral Glucose Tolerance Test in Week 12
2-h serum glucose levels were evaluated at week 12 after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12
Measured: Week 12
Glycosylated Hemoglobin (A1C)
Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12
Measured: Week 12
Secondary outcomes (21)
Total Insulin Secretion
Total insulin secretion was calculated at week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12.
The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.
Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion
Measured: Week 12
Insulin Sensitivity
Insulin sensitivity was calculated at week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12.
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity
Measured: Week 12
First Phase of Insulin Secretion
The first phase of insulin secretion was calculated at week 12 with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12.
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.
First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
Measured: Week 12
AUC Glucose
Area under the curve (AUC) of glucose was calculated with the polygonal formula.
The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia.
Measured: Week 12
AUC Insulin
Area under the curve (AUC) of insulin was calculated with the polygonal formula.
The area under the curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia.
Measured: Week 12
Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week
The glucose levels 30' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 30' at week 12
Measured: Week 12
Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week
The glucose levels 60' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 60' at week 12
Measured: Week 12
Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week
The glucose levels 90' were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the glucose 90' at week 12.
Measured: Week 12
Waist Circumference
Waist circumference was evaluated at week 12 with a flexible tape
Measured: Week 12
Body Weight
The body weight was measured at week 12 with a bioimpedance balance and the entered values reflect the body weight at week 12
Measured: Week 12
Body Mass Index
Body Mas Index was calculated at week 12 with the Quetelet index formula and the entered values reflect the body mass index at week 12
Measured: Week 12
Percentage of Fat Mass
Percentage of fat mass was evaluated through bioimpedance.
Measured: Week 12
Total Cholesterol
Total cholesterol levels were evaluated at week 12 by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Measured: Week 12
Triglycerides
Triglycerides levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Measured: Week 12
High Density Lipoprotein Cholesterol (c-HDL)
c-HDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Measured: Week 12
Low Density Lipoproteins Cholesterol (c-LDL)
c-LDL levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-LDL level at week 12
Measured: Week 12
Very Low Density Lipoprotein (c-VLDL)
Very low density lipoprotein (c-VLDL) was analyzed with the cholesterol oxidase/peroxidase technique by enzymatic colorimetric methods on an automatic analyzer.
Measured: Week 12
Creatinine
Creatinine levels were evaluated at week 12 with enzymatic/colorimetric techniques
Measured: Week 12
Uric Acid
Uric acid levels were evaluated at week 12 with enzymatic/colorimetric techniques
Measured: Week 12
Systolic Blood Pressure
The systolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12.
Measured: Week 12
Diastolic Blood Pressure
The diastolic blood pressure was evaluated at week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start30 Jan 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel González Ortiz, University of Guadalajara
- Investigators
- MANUEL GONZALEZ, PhD, Principal investigator, Intstituto de Terapeútica Experimental y Clínica.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416127
- Sponsor's protocol ID
- PROPOLIS-METFORMIN-DM2
- Status last verified
- Nov 2022
- First submitted
- 23 Jan 2018
- Last updated
- 7 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus Without Pharmacological Treatment
- ClinicalTrials.gov ID
- NCT03416127
- Acronym / sponsor ID
- PROPOLIS-METFORMIN-DM2
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus type 2, Glycemic control, Propolis, Metformin, Pharmacological treatment-naïve patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Posted 9 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the effect of propolis or metformin on glycemic control in patients with type 2 diabetes mellitus without pharmacological treatment.
All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index, and Matsuda index were measured.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without pharmacological treatment.
At the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas under the curve of glucose and insulin, total insulin secretion insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated.
All patients received for 12 weeks two capsules a day, one before the first bite of breakfast and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12 received metformin (850 mg), and 12 more placebo in the same pharmacological presentation.
This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.
Results are presented as mean and standard deviation. Intra-group differences were evaluated using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated with the Wilcoxon test; p≤0.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propolis | Experimental | Drug: PropolisPropolis 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules, 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 (7 listed)
- Patients both sexes
- Age between 30 and 60 years
- Mild to moderate physical activity
- Stable body weight for at least 12 weeks prior to the study
- BMI 25.0 - 34.9 kg/m2
Key exclusion criteria (9 listed)
- Women with confirmed or suspected pregnancy
- Women under lactation and/or puerperium
- Previous treatment for glucose
- Fasting glucose ≥250 mg/dL
- 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 |
|---|---|---|
| PropolisPropolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks. | Drug | Propolis |
| MetforminAlso: Metformin hydrochlorideMetformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks. | Drug | Metformin |
| PlaceboAlso: Calcined magnesiumCalcined magnesium, two times per day before break-fast and dinner during 12 weeks. | Drug | Placebo |
Primary outcome
Fasting Serum Glucose
Time frame: Week 12
The fasting glucose levels were evaluated at week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
2 Hours After Oral Glucose Tolerance Test in Week 12
Time frame: Week 12
2-h serum glucose levels were evaluated at 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 (A1C)
Time frame: Week 12
Glycosylated hemoglobin was evaluated at week 12 by high pressure liquid chromatography (HPLC) and the entered values reflect the glycosylated hemoglobin at week 12
21 secondary outcomes
Total Insulin Secretion
Time frame: Week 12
Insulin Sensitivity
Time frame: Week 12
First Phase of Insulin Secretion
Time frame: Week 12
AUC Glucose
Time frame: Week 12
AUC Insulin
Time frame: Week 12
Glucose 30 Min After Oral Glucose Tolerance Test at 12 Week
Time frame: Week 12
Glucose 60 Min After Oral Glucose Tolerance Test at 12 Week
Time frame: Week 12
Glucose 90 Min After Oral Glucose Tolerance Test at 12 Week
Time frame: Week 12
Waist Circumference
Time frame: Week 12
Body Weight
Time frame: Week 12
Body Mass Index
Time frame: Week 12
Percentage of Fat Mass
Time frame: Week 12
Total Cholesterol
Time frame: Week 12
Triglycerides
Time frame: Week 12
High Density Lipoprotein Cholesterol (c-HDL)
Time frame: Week 12
Low Density Lipoproteins Cholesterol (c-LDL)
Time frame: Week 12
Very Low Density Lipoprotein (c-VLDL)
Time frame: Week 12
Creatinine
Time frame: Week 12
Uric Acid
Time frame: Week 12
Systolic Blood Pressure
Time frame: Week 12
Diastolic Blood Pressure
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, PhD principal investigator
Intstituto de Terapeútica Experimental y Clínica.
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 Propolis and Metformin in people with Diabetes Mellitus, Type 2, 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 7 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: finished, as of the sponsor's last update on 7 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Serum Glucose (time frame: Week 12). The study lists 3 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 Nov 2022.