Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity

February 18, 2024 updated by: HÜMEYRA ACIKAN

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Melikgazi
      • Kayseri̇, Melikgazi, Turkey, 38030
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: obesity

Children with obesity were recommended to have a diet appropriate for their age and gender and exercise at least 3 days a week for at least 60 minutes each time.

All obese children under the age of 14 were started on metformin treatment at 1000 mg (500 mgx2) per day, and children over this age were started on metformin treatment at the adult dose of 2000 mg (1000 mgx2) per day.
Drug: Metformin
Only obese children with insulin resistance were treated with metformin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance (HOMA-IR) level
Time Frame: three months
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
Weight loss rate
Time Frame: three months
Weight loss rate is typically defined as the amount of weight lost over a specific period of time.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HÜMEYRA ACIKAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2019

Primary Completion (Actual)

August 20, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-TF-HA-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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