Metabolic SyndromePhase 3NCT02778776
Combination of Metformine/Inulin Versus Metformin on Prostate Benign Hyperplasia in Metabolic Syndrome
A Phase 3 study testing Metformin and Agave inulin in people with Metabolic Syndrome, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial summary
Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid metabolism, especially triglyceride and hypertension are metabolic disorders that play a central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular morbidity and mortality associated with… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Metformin and Agave inulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2013to Jun 2015
- Phase
- Phase 3
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of metabolic syndrome by IDF criteria
- a person to be defined as having the metabolic syndrome they must have: Central obesity (defined as waist circumference* with ethnicity specific values) ≥80 cm in females and ≥90 cm in males; and plus any two of the following four factors:
- Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL cholesterol
- < 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females or specific treatment for this lipid abnormality
- Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
- Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
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- Age ranging from 40 to 80 years old
- Male patients
- Informed written consent
Who cannot join
- Kidney disease
- Hepatic disease
- Thyroid disease
- Diabetes mellitus
- Ischemic heart disease
- Drug consumption
Show all 10Show fewer
- Alcohol consumption of more than 2 ounces daily
- Consumption of drugs that intervene with lipid or glucose metabolism 2 months before
- Blood pressure >160/100mmHg.
- Lack of adherence to treatment (adherence <80%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Administration of Combination Metformine/Inulin Versus Metformine on Patients With Prostate Benign Hyperplasia and Metabolic Syndrome Syndrome
Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid metabolism, especially triglyceride and hypertension are metabolic disorders that play a central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular morbidity and mortality associated with atherosclerosis, such as myocardial infarction, cerebral vascular events, vascular dementia, heart failure and end stage renal disease. Recently other complications related with hyperinsulinemia like the prostate benign hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome, given its low cost and comparable pharmacological effects to the tiazolinedionas (eg pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty acids and triglycerides, also it produces moderate weight loss, improving the metabolic profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes mellitus in individuals with impaired fasting glucose.
A second option for risk reduction would be the addition of inulin fiber type as it has been demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.
It is expected that combination of metformin with inulin produce a beneficial effect through farmacological synergism and the impact on fisiopatological changes of metabolic syndrome that potentially is considered as an important risk factor for prostate growth.
Read the detailed description
The main objective is to evaluate the effect of the combination of metformin / inulin on clinical, urodynamic parameters as well as metabolic and inflammatory profile in patients with benign prostate hypertrophy and metabolic syndrome.
The investigators conducted a double-blind trial, randomized, on 4 groups, each group with 15 male and female patients of 40 to 80 years of age with METS diagnosed by IDF criteria and clinical diagnose of HBP. Randomization will determine who will receive the intervention during 12 week trial, each group will be like:
Group (A) intervention with combination metformin/ inulin: 15 individuals recieved combination of metformin/ agave inulin in a dosis of 500 mg / 10 grs per 24hrs during 12 weeks.
Group (B) Metformin plus Placebo of agave inulin: 15 individuals recieved Metformin in a dosis of 500mg per day (with the first bite of the second meal) plus homologue placebo of agave inulin (calcinated magnesia) in a dosis of 10grs each 24 hrs during 12 weeks.
Group (C) agave inulin plus placebo of Metformin: 15 indivuduals recieved agave inulin in a dosis of 10grs per 24hrs plus homologate placebo of metformin (calcinated magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 12 weeks.
Group (D) Placebo of agave inulin plus Placebo of Metformin: homologate placebo of agave inulin (calcinated magnesia) in a dosis of 10 grs each 24 hrs plus homologate placebo of metformin (calcinated magnesia capsules) in a dosis of 500 mg per day (with the first bite of the second meal) during 12 weeks.
The clinical findings and laboratory test include a metabolic profile and biosafety, will be baseline and at 12 weeks.
Clinical components of Mets like antropometrics parameters, fasting glucose, fasting insulin, blood lipids, clinical finding of HBP and inflammation parameters and adipocitocins, IGF-1, insulin, prostatic specific antigen. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.
- Conditions
- Metabolic Syndrome
- Being tested
- Metformin, Agave inulin, Placebo of agave inulin, Metformin placebo
- Keywords
- Metformin, Agave Inulin, METS, Inflammation parameters, Urodynamic parameters, Prostate hyperplasia
- Medical subject headings
- Metabolic Syndrome, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called GLUCOPHAGE
Metfomin in tablet presentation of 500 mg
Agave inulinDietary supplement
Oligofructan in powder obtained from agave plant, it was given to each patient a full 10 mg container.
Placebo of agave inulinOther
Calcinated magnesia powder
Metformin placeboOther
Calcinated magnesia tablet
| Study group | Role | What they receive |
|---|---|---|
| Agave inulin + Metfomin | Experimental | 5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs Receives: Drug: Metformin; Dietary Supplement: Agave inulin |
| Metformin + Placebo of agave inulin | Active comparator | 500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder Receives: Drug: Metformin; Other: Placebo of agave inulin |
| Agave Inulin+Placebo of Metformin | Active comparator | 5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs Receives: Dietary Supplement: Agave inulin; Other: Metformin placebo |
| Placebo of Inulin + Placebo of Metformin | Placebo comparator | 5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs Receives: Other: Placebo of agave inulin; Other: Metformin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (I-PSS)
before and after intervention questionnaire
Measured: 12 weeks
Secondary outcomes (11)
Change of waist circumference
Measured with a non elastic tape at baseline and after intervention
Measured: 12 weeks
Change of body mass index
before and after intervention using a tetrapolar bioelectrical impedance analyzer (body composition analyzer TBF-215 - Tanita)
Measured: 12 weeks
Change from baseline in Peripheral systolic blood pressure
Before and after intervention using a digital sphygmomanometer
Measured: 12 weeks
Change from baseline in Peripheral diastolic blood pressure
Before and after intervention using a digital sphygmomanometer
Measured: 12 weeks
Change of HOMA-IR from base line to 12 weeks
Before and after intervention by using the formula for the homeostasis model assessment β-cell function index: 20 x fasting insulin (µU/Ml)/fasting glucose (mmol/L) - 3.5.
Measured: 12 weeks
Change from baseline in High-density lipoprotein cholesterol at 12 weeks
Before and after intervention by spectrophotometry
Measured: 12 weeks
Change from Baseline in Triglycerides at 12 weeks
Before and after intervention by spectrophotometry
Measured: 12 weeks
Change from Baseline in Total cholesterol at 12 weeks
Before and after intervention by spectrophotometry
Measured: 12 weeks
Change from Baseline in Fasting plasma glucose at 12 weeks
Before and after intervention by glucose oxidase
Measured: 12 weeks
qmax urine flow rate
before and after intervention by uroflowmetry
Measured: 12 weeks
prostate serum antigen
before and after intervention by colorimetry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- FERNANDO GROVER, PhD, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778776
- Sponsor's protocol ID
- CUCS-INTEC-MV-HBP-001
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Administration of Combination Metformine/Inulin Versus Metformine on Patients With Prostate Benign Hyperplasia and Metabolic Syndrome Syndrome
- ClinicalTrials.gov ID
- NCT02778776
- Acronym / sponsor ID
- CUCS-INTEC-MV-HBP-001
- Conditions
- Metabolic Syndrome
- Keywords
- Metformin, Agave Inulin, METS, Inflammation parameters, Urodynamic parameters, Prostate hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 May 2016 (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.
Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid metabolism, especially triglyceride and hypertension are metabolic disorders that play a central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular morbidity and mortality associated with atherosclerosis, such as myocardial infarction, cerebral vascular events, vascular dementia, heart failure and end stage renal disease. Recently other complications related with hyperinsulinemia like the prostate benign hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome, given its low cost and comparable pharmacological effects to the tiazolinedionas (eg pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty acids and triglycerides, also it produces moderate weight loss, improving the metabolic profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes mellitus in individuals with impaired fasting glucose.
A second option for risk reduction would be the addition of inulin fiber type as it has been demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.
It is expected that combination of metformin with inulin produce a beneficial effect through farmacological synergism and the impact on fisiopatological changes of metabolic syndrome that potentially is considered as an important risk factor for prostate growth.
Detailed description
The main objective is to evaluate the effect of the combination of metformin / inulin on clinical, urodynamic parameters as well as metabolic and inflammatory profile in patients with benign prostate hypertrophy and metabolic syndrome.
The investigators conducted a double-blind trial, randomized, on 4 groups, each group with 15 male and female patients of 40 to 80 years of age with METS diagnosed by IDF criteria and clinical diagnose of HBP. Randomization will determine who will receive the intervention during 12 week trial, each group will be like:
Group (A) intervention with combination metformin/ inulin: 15 individuals recieved combination of metformin/ agave inulin in a dosis of 500 mg / 10 grs per 24hrs during 12 weeks.
Group (B) Metformin plus Placebo of agave inulin: 15 individuals recieved Metformin in a dosis of 500mg per day (with the first bite of the second meal) plus homologue placebo of agave inulin (calcinated magnesia) in a dosis of 10grs each 24 hrs during 12 weeks.
Group (C) agave inulin plus placebo of Metformin: 15 indivuduals recieved agave inulin in a dosis of 10grs per 24hrs plus homologate placebo of metformin (calcinated magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 12 weeks.
Group (D) Placebo of agave inulin plus Placebo of Metformin: homologate placebo of agave inulin (calcinated magnesia) in a dosis of 10 grs each 24 hrs plus homologate placebo of metformin (calcinated magnesia capsules) in a dosis of 500 mg per day (with the first bite of the second meal) during 12 weeks.
The clinical findings and laboratory test include a metabolic profile and biosafety, will be baseline and at 12 weeks.
Clinical components of Mets like antropometrics parameters, fasting glucose, fasting insulin, blood lipids, clinical finding of HBP and inflammation parameters and adipocitocins, IGF-1, insulin, prostatic specific antigen. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Agave inulin + Metfomin | Experimental | Drug: Metformin, Dietary Supplement: Agave inulin5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs |
| Metformin + Placebo of agave inulin | Active comparator | Drug: Metformin, Other: Placebo of agave inulin500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder |
| Agave Inulin+Placebo of Metformin | Active comparator | Dietary Supplement: Agave inulin, Other: Metformin placebo5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs |
| Placebo of Inulin + Placebo of Metformin | Placebo comparator | Other: Placebo of agave inulin, Other: Metformin placebo5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of metabolic syndrome by IDF criteria
- Age ranging from 40 to 80 years old
- Male patients
- Informed written consent
Key exclusion criteria (10 listed)
- Kidney disease
- Hepatic disease
- Thyroid disease
- Diabetes mellitus
- Ischemic heart disease
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 |
|---|---|---|
| MetforminAlso: GLUCOPHAGEMetfomin in tablet presentation of 500 mg | Drug | Agave inulin + Metfomin, Metformin + Placebo of agave inulin |
| Agave inulinOligofructan in powder obtained from agave plant, it was given to each patient a full 10 mg container. | Dietary supplement | Agave Inulin+Placebo of Metformin, Agave inulin + Metfomin |
| Placebo of agave inulinCalcinated magnesia powder | Other | Metformin + Placebo of agave inulin, Placebo of Inulin + Placebo of Metformin |
| Metformin placeboCalcinated magnesia tablet | Other | Agave Inulin+Placebo of Metformin, Placebo of Inulin + Placebo of Metformin |
Primary outcome
International Prostate Symptom Score (I-PSS)
Time frame: 12 weeks
before and after intervention questionnaire
11 secondary outcomes
Change of waist circumference
Time frame: 12 weeks
Change of body mass index
Time frame: 12 weeks
Change from baseline in Peripheral systolic blood pressure
Time frame: 12 weeks
Change from baseline in Peripheral diastolic blood pressure
Time frame: 12 weeks
Change of HOMA-IR from base line to 12 weeks
Time frame: 12 weeks
Change from baseline in High-density lipoprotein cholesterol at 12 weeks
Time frame: 12 weeks
Change from Baseline in Triglycerides at 12 weeks
Time frame: 12 weeks
Change from Baseline in Total cholesterol at 12 weeks
Time frame: 12 weeks
Change from Baseline in Fasting plasma glucose at 12 weeks
Time frame: 12 weeks
qmax urine flow rate
Time frame: 12 weeks
prostate serum antigen
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Individual participant dataSharing planned: No
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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.
FERNANDO GROVER, PhD principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, 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 3 study testing Metformin and Agave inulin in people with Metabolic Syndrome, run by Centro Universitario de Ciencias de la Salud, Mexico 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 9 inclusion and 10 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 20 May 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
International Prostate Symptom Score (I-PSS) (time frame: 12 weeks). 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 20 May 2016.