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.