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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Childhood Obesity
• Insulin Resistance
• Obesity
• Pediatric Obesity

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