Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity

NCT ID: NCT06266598

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-17

Study Completion Date

2021-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Obesity Insulin Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Metformin

Intervention Type DRUG

Only obese children with insulin resistance were treated with metformin.

Interventions

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Metformin

Only obese children with insulin resistance were treated with metformin.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HÜMEYRA ACIKAN

OTHER

Sponsor Role lead

Responsible Party

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HÜMEYRA ACIKAN

Research asistant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Erciyes University

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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EU-TF-HA-01

Identifier Type: -

Identifier Source: org_study_id

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