Evaluating green tea's effects on obese children with prediabetes
Effect of Green Tea on Obese Pediatrics With Prediabetes
This study is testing whether green tea can help obese children with prediabetes improve their blood sugar and overall health compared to just taking metformin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06229795 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of green tea in treating obese pediatric patients with prediabetes, comparing it to metformin therapy alone. The study will measure insulin resistance using HOMA-IR levels, as well as blood glucose levels and glycated hemoglobin. Additionally, it will evaluate the impact of green tea on lipid profiles, leptin, adiponectin, and various oxidative and inflammatory markers. Conducted as a prospective parallel randomized open-label controlled trial, it will take place at the children's endocrinology unit of El-Demerdash hospital.
Who should consider this trial
Good fit: Ideal candidates are obese children aged 10 to 18 years with a HOMA IR greater than 2.5.
Not a fit: Patients with HOMA IR less than 2.5 or those with other comorbidities such as thyroid dysfunction or cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to help manage insulin resistance and prevent the progression of prediabetes to type 2 diabetes in children.
How similar studies have performed: While the use of green tea for metabolic conditions is explored, this specific approach in pediatric prediabetes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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...
Where this trial is running
Cairo
- El-Demerdash hospital — Cairo, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.