Effect of Green Tea Extract on Arterial Stiffness in Type 2 Diabetes Mellitus
Effect of Green Tea Extract Administration on Arterial Stiffness in Patients With Type 2 Diabetes Mellitus
Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
This PHASE2 trial investigates Type 2 Diabetes Mellitus and is currently completed. Centro Universitario de Ciencias de la Salud, Mexico leads this study, which shows 7 recorded versions since 2016 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
-
Feb 2018 — Jun 2018 [monthly]
Completed PHASE2
Status: Not Yet Recruiting → Completed
-
Jan 2017 — Feb 2018 [monthly]
Not Yet Recruiting PHASE2
First recorded
Jan 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Centro Universitario de Ciencias de la Salud, Mexico
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.