deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02627898

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

Updated 7 times since 2017 Last updated: Jan 23, 2018 Started: Jan 31, 2016 Primary completion: Sep 30, 2016 Completion: Dec 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2018 · 13 months · monthly snapshotNot Yet Recruiting~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

Show 2 earlier versions
  1. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE2

    Status: Not Yet RecruitingCompleted

  2. 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

Sponsor contact:
  • Centro Universitario de Ciencias de la Salud, Mexico
Data source: Centro Universitario de Ciencias de la Salud, Mexico

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.