Type 2 Diabetes MellitusPhase 2NCT02627898
Effect of Green Tea Extract on Arterial Stiffness in Type 2 Diabetes Mellitus
A Phase 2 study testing green tea extract in people with Type 2 Diabetes Mellitus, run by Centro Universitario de Ciencias de la Salud, Mexico.
Trial summary
Type 2 diabetes mellitus (T2DM) has become the epidemic of the XXI century. This chronic disease is also highly prevalent and primarily associated with an increased cardiovascular mortality and morbidity due to micro and macrovascular complications, where its pathophysiological mechanism accelerates the formation of… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- green tea extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 2
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T2DM
- Fasting plasma glucose >126 and <250 mg/dl at the time security
- Metformin monotherapy or with glibenclamide added
- Written informed consent
Who cannot join
- Hypertention
- Treated with insulin
- Use of antioxidant suplements or products with caffeine
- Woman pregnant or breastfeeding
- Untreated tyroid disease
- Total colesterol >400mg/dl
Show all 9Show fewer
- Triglycerides >400mg/dl
- Liver enzimes (alt and ast) more tan twice the normal range
- Glomerular filtration rate <60ml/min (Cockcroft-Gault)
About this study
Official title: Effect of Green Tea Extract Administration on Arterial Stiffness in Patients With Type 2 Diabetes Mellitus
Type 2 diabetes mellitus (T2DM) has become the epidemic of the XXI century. This chronic disease is also highly prevalent and primarily associated with an increased cardiovascular mortality and morbidity due to micro and macrovascular complications, where its pathophysiological mechanism accelerates the formation of the atherosclerotic process, fundamental element associated with arterial stiffness. The importance of anticipating the presence of a cardiovascular event lies precisely in the early detection of subclinical changes in the elastic arteries identified by measuring the pulse wave velocity. Having adequate pharmacological or non-pharmacological interventions that impact precisely in the reduction of pulse wave velocity contributes to a reduction of cardiovascular morbidity and mortality associated with DM2. Among non-pharmacological therapies they have been studied the benefits attributed to the use of green tea infusion either encapsulated or extract have been associated mainly with anti-inflammatory and antioxidant effects. There are both experimental and clinical studies that have shown benefits of administration of green tea (extract or infusion), and administered by different routes at different dosages and for varying times. But it has been noted that not all studies with green tea meet appropriate to draw conclusions about its benefits to cardiovascular level. However, it is proposed that the use of green tea extract with a highest amount of catechins through a controlled clinical trial could be a potential therapeutic strategy for changing hemodynamic alterations and arterial stiffness favorably in this particular group of patients DM2.
Read the detailed description
The objetive is to evaluate the effect of administration of Green tea exctract on arterial stiffness in individuals with T2DM. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 male and female patients of 35-65 years of age with T2DM, with no hypertension or treated with insulins. Randomization will determine who will receive the intervention during 8 week trial (Green tea extract capsule, 400 mg 1 time daily with the first bite of each meal or approved placebo capsules), both groups also will continue with their usual treatment. The clinical findings and laboratory test include a metabolic profile and biosafety, wich will be baseline and at 8 weeks. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the inicial and final visit, likewise, hemodynamics parameters of arterial stiffness like the aortic pulse wave velocity (PWVao), central pulse pressure (PPao), aortic augmentation index (IAxao) and central systolic blood pressure (cSBP) by an oscillometric monitoring system via BPLab ®. Adverse events and adherence to treatment will be documented. The statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. It is considered with significance at p<0.05.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- green tea extract, placebo
- Keywords
- Green tea extract, Arterial stiffness, PWVao
- 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.
green tea extractDrug
Also called Sunphenon 90LB
Green tea extract capsules, 400mg 1 time daily with the first bite of eat meal
placeboDrug
Also called Calcined magnesia
Placebo capsules, 400mg 1 time daily with the first bite of eat meal
| Study group | Role | What they receive |
|---|---|---|
| Green tea extract | Experimental | Individuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim Receives: Drug: green tea extract |
| Placebo | Placebo comparator | Individuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Aortic Pulse Wave Velocity measured in meters / second, at 12 weeks
Before and after intervention with oscillometric monitoring system via BPLab
Measured: baseline and 12 weeks
Secondary outcomes (3)
Change from Baseline in aortic pulse pressure measured in mm / Hg at 12 weeks
Before and after intervention with oscillometric monitoring system via BPLab
Measured: baseline and 12 weeks
Change from Baseline in aortic Augmentation index measured in percentage at 12 weeks
Before and after intervention with oscillometric monitoring system via BPLab
Measured: baseline and 12 weeks
Change from Baseline in central systolic blood pressure measured in mm / Hg at 12 weeks
Before and after intervention with oscillometric monitoring system via BPLab
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 24 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627898
- Sponsor's protocol ID
- CUCS-INTEC-MV-TEVE-001
- Status last verified
- Jan 2018
- First submitted
- 3 Dec 2015
- Last updated
- 25 Jan 2018
- 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 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Green Tea Extract Administration on Arterial Stiffness in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02627898
- Acronym / sponsor ID
- CUCS-INTEC-MV-TEVE-001
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Green tea extract, Arterial stiffness, PWVao
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Dec 2015 (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 (T2DM) has become the epidemic of the XXI century. This chronic disease is also highly prevalent and primarily associated with an increased cardiovascular mortality and morbidity due to micro and macrovascular complications, where its pathophysiological mechanism accelerates the formation of the atherosclerotic process, fundamental element associated with arterial stiffness. The importance of anticipating the presence of a cardiovascular event lies precisely in the early detection of subclinical changes in the elastic arteries identified by measuring the pulse wave velocity. Having adequate pharmacological or non-pharmacological interventions that impact precisely in the reduction of pulse wave velocity contributes to a reduction of cardiovascular morbidity and mortality associated with DM2. Among non-pharmacological therapies they have been studied the benefits attributed to the use of green tea infusion either encapsulated or extract have been associated mainly with anti-inflammatory and antioxidant effects. There are both experimental and clinical studies that have shown benefits of administration of green tea (extract or infusion), and administered by different routes at different dosages and for varying times. But it has been noted that not all studies with green tea meet appropriate to draw conclusions about its benefits to cardiovascular level. However, it is proposed that the use of green tea extract with a highest amount of catechins through a controlled clinical trial could be a potential therapeutic strategy for changing hemodynamic alterations and arterial stiffness favorably in this particular group of patients DM2.
Detailed description
The objetive is to evaluate the effect of administration of Green tea exctract on arterial stiffness in individuals with T2DM. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 male and female patients of 35-65 years of age with T2DM, with no hypertension or treated with insulins. Randomization will determine who will receive the intervention during 8 week trial (Green tea extract capsule, 400 mg 1 time daily with the first bite of each meal or approved placebo capsules), both groups also will continue with their usual treatment. The clinical findings and laboratory test include a metabolic profile and biosafety, wich will be baseline and at 8 weeks. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the inicial and final visit, likewise, hemodynamics parameters of arterial stiffness like the aortic pulse wave velocity (PWVao), central pulse pressure (PPao), aortic augmentation index (IAxao) and central systolic blood pressure (cSBP) by an oscillometric monitoring system via BPLab ®. Adverse events and adherence to treatment will be documented. The 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Green tea extract | Experimental | Drug: green tea extractIndividuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim |
| Placebo | Placebo comparator | Drug: placeboIndividuals with T2DM controlled with metformin or glibenclamide, or both; with no hypertension neither treated with insulim |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of T2DM
- Fasting plasma glucose >126 and <250 mg/dl at the time security
- Metformin monotherapy or with glibenclamide added
- Written informed consent
Key exclusion criteria (9 listed)
- Hypertention
- Treated with insulin
- Use of antioxidant suplements or products with caffeine
- Woman pregnant or breastfeeding
- Untreated tyroid 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 |
|---|---|---|
| green tea extractAlso: Sunphenon 90LBGreen tea extract capsules, 400mg 1 time daily with the first bite of eat meal | Drug | Green tea extract |
| placeboAlso: Calcined magnesiaPlacebo capsules, 400mg 1 time daily with the first bite of eat meal | Drug | Placebo |
Primary outcome
Change from Baseline in Aortic Pulse Wave Velocity measured in meters / second, at 12 weeks
Time frame: baseline and 12 weeks
Before and after intervention with oscillometric monitoring system via BPLab
3 secondary outcomes
Change from Baseline in aortic pulse pressure measured in mm / Hg at 12 weeks
Time frame: baseline and 12 weeks
Change from Baseline in aortic Augmentation index measured in percentage at 12 weeks
Time frame: baseline and 12 weeks
Change from Baseline in central systolic blood pressure measured in mm / Hg at 12 weeks
Time frame: baseline and 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 25 Jan 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing green tea extract in people with Type 2 Diabetes Mellitus, run by Centro Universitario de Ciencias de la Salud, 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 4 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 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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 in Aortic Pulse Wave Velocity measured in meters / second, at 12 weeks (time frame: baseline and 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 25 Jan 2018.