Effect of Green Tea on Obese Pediatrics With Prediabetes

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. Thyroid functions (TSH/T3): to rule out any other endocrine causes of obesity. Cortisol levels (am and pm): to rule out any other endocrine causes of obesity. The following laboratory' measurements will be tested at baseline and at the end of study (4 months): Complete Blood Picture, fasting blood glucose and postprandial blood 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 2 weeks 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: Recruiting
• Conditions: PreDiabetes
• Intervention / Treatment: Drug: Green Tea Leaf Extract Decaffeinated; Drug: Metformin Hydrochloride 500 MG

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • El-Demerdash hospital
    • Contact: Mona Rashad Aly, Professor; Phone Number: 0114829222
    • Principal Investigator: Nagwa Ali Sabri, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Metformin 500 mg tablet twice 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 twice daily	Drug: Metformin Hydrochloride 500 MG; 500 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on	Homeostatic model assessment for insulin resistance (HOMA-IR)	At 0 weeks then after 12 weeks
Effect on	Glycated hemoglobin (HbA1c)	At 0 weeks then after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on	lipid profile	At 0 weeks then after 12 weeks
Effect on	leptin	At 0 weeks then after 12 weeks
Effect on	adiponectin	At 0 weeks then after 12 weeks
Effect on	Malondialdehyde (MDA) oxidative stress marker	At 0 weeks then after 12 weeks
Effect on	Nuclear factor kappa beta (NF-KB) inflammatory marker	At 0 weeks then after 12 weeks
Effect on	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 12 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 21, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Prediabetes, green tea, pediatrics, children, insulin resistance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID 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