Metabolic SyndromePhase 3NCT02773927
Combination of Metformin/Inulin vs Inulin on Adiponectin 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
Presence of metabolic syndrome (MetS) and its relation with insulin resistance, obesity, dyslipidemia, systemic inflammation and cardiovascular disease is of great concern. The study of certain adipokines such as adiponectin has demonstrated an inverse association with insulin resistance, especially in Latin… 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
Show all 9Show fewer
- 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 >160/100 mmHg.
- Lack of adherence to treatment (adherence <80%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Combination Metformin/Inulin vs Inulin on Adiponectin in Patients With Metabolic Syndrome
Presence of metabolic syndrome (MetS) and its relation with insulin resistance, obesity, dyslipidemia, systemic inflammation and cardiovascular disease is of great concern. The study of certain adipokines such as adiponectin has demonstrated an inverse association with insulin resistance, especially in Latin population lower levels of adiponectin have been observed compared to other ethnic groups. It appears to be an important molecule that is involved in limiting the pathogenesis of obesity-linked disorders and may have potential benefits as a marker to evaluate the effect of possible interventions on the MetS components and its complications.
Metformin is treatment of choice in patients with MetS, due to its low cost and pharmacological comparable effects with thiazolidinediones (pioglitazone), it decreases hyperinsulinemia, insulin resistance, free fatty acids and triglycerides, it produces as well, a moderate weight loss, improves lipid profile and delays the appearance of diabetes mellitus in subjects with an abnormal fasting glucose.
Read more
A second choice to lower the risks would be the addition of a fiber like inulin, a prebiotic, since it has demonstrated metabolic benefits on lipid and carbohydrates metabolism by several mechanisms proposed such as induction of lipogenic enzymes by glucose, production of short-chained fatty acids, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1), and growth of Bifidobacterium. A good natural source of inulin is the agave.
It is expected that the combination of metformin plus agave inulin will produce a beneficial impact through pharmacological synergism and that will produce changes in the pathophysiology of MetS.
Read the detailed description
The main objective was to compare the effect of the administration of Metformin/agave inulin vs. Agave inulin on adiponectin in patients with MetS. The investigators conducted a double-blinded randomized trial, on 4 groups, each group with 10 male patients of 40-80 years of age with METS diagnosed by International Diabetes Federation (IDF) criteria. Randomization determined the group assignation during the 12-week trial, each group consisted of:
Group (A) Metformin plus agave inulin: 10 individuals received metformin in a dosis of 500 mg per day (1 tablet of 500 mg) plus inulin in a dosis of 10 mg per day (5 mg every 12 hours) during 12 weeks.
Group (B) Metformin plus Placebo of agave inulin: 10 individuals received Metformin in a dosis of 500mg per day (with the first bite of the second meal) plus homologue placebo of inulin (calcinated magnesia) in a dosis of 10 mg every 24 hrs (5 mg of calcinated magnesia powder every 12 hours) during 12 weeks.
Group (C) Agave inulin plus Placebo of Metformin: 10 individuals received inulin in a dosis of 10 mg every 24 hrs (5 mg every 12 hours) 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 Inulin (calcinated magnesia powder) in a dosis of 10 mg every 24 hrs (5 mg every 12 hours) 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 included a metabolic profile and biosafety, which was determined at baseline and at 12 weeks.
Waist, body weight, body fat, body mass index (BMI) and blood pressure were determined at baseline, follow up and final visit, likewise, a blood sample was obtained, centrifuged and stored at -80° degrees Celsius to be analyzed after within 30 days. The investigators assessed glucose, total cholesterol, c-HDL, c-LDL, triglycerides by enzymatic techniques, and adiponectin and insulin by ELISA. Insulin resistance (IR) was estimated by the homeostasis model assessment (HOMA) with the formula for the HOMA (fasting insulin mcg/L x (fasting glucose (mmol/L)/22.5) Adverse events and adherence to treatment were documented every 4 weeks.
Statistical analysis: Values were expressed as mean and standard deviation. Mann-Whitney U Test, Wilcoxon exact test and Kruskal-Wallis. A statistical significance was set at p<0.05.
- Conditions
- Metabolic Syndrome
- Being tested
- Metformin, Agave inulin, Placebo of agave inulin, Metformin placebo
- Keywords
- Agave inulin, Adiponectin, Metabolic syndrome, Metformin, Insulin resistance
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called GLUCOPHAGE
Metformin in tablet presentation of 500 mg
Agave inulinDietary supplement
Inulin 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 + Metformin | 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.
Change from Baseline on adiponectin levels (ng/mL) at 12 weeks
Before and after intervention determination of adiponectin using ELISA following the suppliers recommendations
Measured: 12 weeks
Secondary outcomes (10)
Change from Baseline in Fasting plasma glucose at 12 weeks
Before and after intervention by glucose oxidase
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 Triglycerides at 12 weeks
Before and after intervention by spectrophotometry
Measured: 12 weeks
Change from baseline in High-density lipoprotein cholesterol at 12 weeks
Before and after intervention by spectrophotometry
Measured: 12 weeks
Changes of Insulin levels from baseline to 12 weeks
Before and after intervention by ELISA
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 index (FI x (fasting glucose (mmol/l)/22.5)
Measured: 12 weeks
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- 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
- NCT02773927
- Sponsor's protocol ID
- CUCS-INTEC-MV-HBP-002
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 18 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 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Combination Metformin/Inulin vs Inulin on Adiponectin in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02773927
- Acronym / sponsor ID
- CUCS-INTEC-MV-HBP-002
- Conditions
- Metabolic Syndrome
- Keywords
- Agave inulin, Adiponectin, Metabolic syndrome, Metformin, Insulin resistance
- 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
- Jan 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 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.
Presence of metabolic syndrome (MetS) and its relation with insulin resistance, obesity, dyslipidemia, systemic inflammation and cardiovascular disease is of great concern. The study of certain adipokines such as adiponectin has demonstrated an inverse association with insulin resistance, especially in Latin population lower levels of adiponectin have been observed compared to other ethnic groups. It appears to be an important molecule that is involved in limiting the pathogenesis of obesity-linked disorders and may have potential benefits as a marker to evaluate the effect of possible interventions on the MetS components and its complications.
Metformin is treatment of choice in patients with MetS, due to its low cost and pharmacological comparable effects with thiazolidinediones (pioglitazone), it decreases hyperinsulinemia, insulin resistance, free fatty acids and triglycerides, it produces as well, a moderate weight loss, improves lipid profile and delays the appearance of diabetes mellitus in subjects with an abnormal fasting glucose.
A second choice to lower the risks would be the addition of a fiber like inulin, a prebiotic, since it has demonstrated metabolic benefits on lipid and carbohydrates metabolism by several mechanisms proposed such as induction of lipogenic enzymes by glucose, production of short-chained fatty acids, glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1), and growth of Bifidobacterium. A good natural source of inulin is the agave.
It is expected that the combination of metformin plus agave inulin will produce a beneficial impact through pharmacological synergism and that will produce changes in the pathophysiology of MetS.
Detailed description
The main objective was to compare the effect of the administration of Metformin/agave inulin vs. Agave inulin on adiponectin in patients with MetS. The investigators conducted a double-blinded randomized trial, on 4 groups, each group with 10 male patients of 40-80 years of age with METS diagnosed by International Diabetes Federation (IDF) criteria. Randomization determined the group assignation during the 12-week trial, each group consisted of:
Group (A) Metformin plus agave inulin: 10 individuals received metformin in a dosis of 500 mg per day (1 tablet of 500 mg) plus inulin in a dosis of 10 mg per day (5 mg every 12 hours) during 12 weeks.
Group (B) Metformin plus Placebo of agave inulin: 10 individuals received Metformin in a dosis of 500mg per day (with the first bite of the second meal) plus homologue placebo of inulin (calcinated magnesia) in a dosis of 10 mg every 24 hrs (5 mg of calcinated magnesia powder every 12 hours) during 12 weeks.
Group (C) Agave inulin plus Placebo of Metformin: 10 individuals received inulin in a dosis of 10 mg every 24 hrs (5 mg every 12 hours) 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 Inulin (calcinated magnesia powder) in a dosis of 10 mg every 24 hrs (5 mg every 12 hours) 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 included a metabolic profile and biosafety, which was determined at baseline and at 12 weeks.
Waist, body weight, body fat, body mass index (BMI) and blood pressure were determined at baseline, follow up and final visit, likewise, a blood sample was obtained, centrifuged and stored at -80° degrees Celsius to be analyzed after within 30 days. The investigators assessed glucose, total cholesterol, c-HDL, c-LDL, triglycerides by enzymatic techniques, and adiponectin and insulin by ELISA. Insulin resistance (IR) was estimated by the homeostasis model assessment (HOMA) with the formula for the HOMA (fasting insulin mcg/L x (fasting glucose (mmol/L)/22.5) Adverse events and adherence to treatment were documented every 4 weeks.
Statistical analysis: Values were expressed as mean and standard deviation. Mann-Whitney U Test, Wilcoxon exact test and Kruskal-Wallis. A statistical significance was set 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 + Metformin | 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: GLUCOPHAGEMetformin in tablet presentation of 500 mg | Drug | Agave inulin + Metformin, Metformin + Placebo of agave inulin |
| Agave inulinInulin 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 + Metformin |
| 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
Change from Baseline on adiponectin levels (ng/mL) at 12 weeks
Time frame: 12 weeks
Before and after intervention determination of adiponectin using ELISA following the suppliers recommendations
10 secondary outcomes
Change from Baseline in Fasting plasma glucose at 12 weeks
Time frame: 12 weeks
Change from Baseline in Total cholesterol at 12 weeks
Time frame: 12 weeks
Change from Baseline in Triglycerides at 12 weeks
Time frame: 12 weeks
Change from baseline in High-density lipoprotein cholesterol at 12 weeks
Time frame: 12 weeks
Changes of Insulin levels from baseline to 12 weeks
Time frame: 12 weeks
Change of HOMA-IR from base line to 12 weeks
Time frame: 12 weeks
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
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 18 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 18 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?
Change from Baseline on adiponectin levels (ng/mL) at 12 weeks (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 18 May 2016.