Effect of Green Tea on Obese Pediatrics With Prediabetes

January 4, 2026 updated by: Sylvia Yousry Kamel Megaly, Ain Shams University

The aim of this research is to evaluate the safety and efficacy of green tea in obese pediatrics with prediabetes versus the metformin therapy alone that is given to these patients. The primary outcome is to tackle the insulin resistance in these patients to prevent the deterioration of prediabetes to type 2 diabetes. The assessment of the effect on insulin resistance by using homeostatic model assessment for insulin resistance (HOMA-IR levels) as well as the effect on blood glucose levels and glycated hemoglobin. The other primary outcome is to observe the effect of the intervention on the lipid profile, leptin and adiponectin. The secondary outcome is to determine the effect of green tea on the oxidative and inflammatory markers and to evaluate its safety and efficacy. The study design is prospective parallel randomized open- label controlled interventional clinical trial that will be conducted in El-Demerdash hospital children's endocrinology unit. The patients who fit the inclusion criteria will be educated about the study protocol and will be required to sign a written informed consent. The inclusion criteria are: children whose age is between 10 to 18, whose HOMA-IR >2.5, BMI >= 95th percentile and have no sensitivity towards green tea and willing to sign informed consent. Patients who have causes of endogenous obesity will be excluded and those who have any other comorbid conditions. All patients fulfilling the inclusion criteria will be randomly assigned by simple randomization into either Group 1 (Control group): Consists of 45 patients who will receive their conventional therapy which is Metformin 500 mg film coated tablets (Glucophage).

Group 2 (Interventional group): Consists of 45 patients who will receive Green Tea 300 mg (Green tea 300 mg film coated tablets Mepaco Egypt) thrice daily + Metformin 500 mg film coated tablets (Glucophage). At baseline the following parameters will be collected during patients' interview and from patients' files: Demographic data as age, sex, weight and height (BMI), family history, medical history, medication history. The following laboratory' measurements will be tested at baseline and at the end of study (4 months): fasting plasma glucose, fasting plasma insulin, homeostatic model assessment for insulin resistance, homeostatic model assessment for β-cell function, lipid profile, leptin, adiponectin, malondialdehyde, liver functions, kidney functions, c-reactive protein, nuclear factor kappa beta.

Patients will be educated about the side effects and/or adverse effects of green tea, where safety and tolerability will be monitored by reporting the incidence of any side effect and /or adverse effect such as liver problems, yellowing of the color of skin or white of the eyes or stomach pain. Participants will be followed up during the study period every week through clinic visits and by phone in order to assure compliance as well as monitoring of incidence of any side/adverse effects and informing the patients who to handle it.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • El-Demerdash hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Homeostatic Model Assessment for Insulin Resistance (HOMA IR) >2.5
  2. BMI >= 95th percentile according to CDC percentile charts
  3. Age from 10 to 18 years.
  4. Willing to sign a written informed consent through their caregivers.
  5. Absence of sensitivity and/or known allergies for green tea.

Exclusion Criteria:

  1. Homeostatic Model Assessment for Insulin Resistance (HOMA IR) <2.5
  2. Endogenous obesity eg; thyroid dysfunction and adrenal glands dysfunction.
  3. Presence of any other comorbidities as: cardiovascular, renal, liver etc…

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Metformin 500 mg tablet once daily and Green tea 300 mg film coated tablet three times daily.
Drug: Green Tea Leaf Extract Decaffeinated
300 mg film coated tablet
Drug: Metformin Hydrochloride 500 MG
500 mg tablet
Active Comparator: Control
Metformin 500 mg tablet once daily
Drug: Metformin Hydrochloride 500 MG
500 mg tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect on
Time Frame: At 0 weeks then after 16 weeks
Homeostatic model assessment for insulin resistance (HOMA-IR)
At 0 weeks then after 16 weeks
Effect on
Time Frame: At 0 weeks then after 16 weeks
Glycated hemoglobin (HbA1c)
At 0 weeks then after 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect on
Time Frame: At 0 weeks then after 16 weeks
lipid profile
At 0 weeks then after 16 weeks
Effect on
Time Frame: At 0 weeks then after 16 weeks
leptin
At 0 weeks then after 16 weeks
Effect on
Time Frame: At 0 weeks then after 16 weeks
adiponectin
At 0 weeks then after 16 weeks
Effect on
Time Frame: At 0 weeks then after 16 weeks
Malondialdehyde (MDA) oxidative stress marker
At 0 weeks then after 16 weeks
Effect on
Time Frame: At 0 weeks then after 16 weeks
Nuclear factor kappa beta (NF-KB) inflammatory marker
At 0 weeks then after 16 weeks
Effect on
Time Frame: At 0 weeks then after 16 weeks
Number of participants with treatment related adverse effects by using side effects card given to patients and performing liver function tests AST/ALT
At 0 weeks then after 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Green tea on obese pediatrics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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