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NCT06266598 Clinical Trial

Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity

Insulin Resistance Clinical Trial

Official title:
The Effect of Anti-diabetic Treatment Applied in Childhood Obesity on Zinc, Zinc α-2 Glycoprotein and Peroxisome Proliferation Activating Receptor-γ Levels

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06266598
Other study ID # EU-TF-HA-01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 17, 2019
Est. completion date October 27, 2021

Study information
Verified date February 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. To observe the efficacy of the 3-month treatment before and after metformin treatment, Zn, Zinc α-2 Glycoprotein (ZAG), Peroxisome proliferation activating receptor γ (PPARγ), Leptin (LEP) and Adiponectin (ADIPO) levels were compared, as well as anthropometric measurements and routine biochemistry tests.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date October 27, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 18 Years
Eligibility inclusion criteria: - Body mass index (BMI) > 95th percentile - Having insulin resistance - Having a family history of Type 2 diabetes mellitus (T2DM) exclusion criteria; - Alcohol consumption and smoking - Having T1DM and T2DM - History of drug use

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin
Only obese children with insulin resistance were treated with metformin.

Locations
Country Name City State
Turkey Erciyes University Kayseri? Melikgazi

Sponsors (1)
Lead Sponsor Collaborator
HÜMEYRA ACIKAN

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Insulin resistance (HOMA-IR) level HOMA-IR is a condition in which the body's cells become less responsive to the effects of insulin. This means that the body needs more insulin to achieve the same effects, such as regulating blood sugar levels three months
Primary Weight loss rate Weight loss rate is typically defined as the amount of weight lost over a specific period of time. three months
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