Effectiveness of Antidiabetic Treatment Applied in Childhood Obesity

NCT06266598 | Completed Phase 4

• 1 other identifier: EU-TF-HA-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Obesity; Insulin Resistance

Keywords

Obesity; Metformin; Biomarker

Outcome Measures

Primary Outcomes (2)

• 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

• Weight loss rate

  Weight loss rate is typically defined as the amount of weight lost over a specific period of time.

  three months

Study Arms (1)

obesity

OTHER

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

Interventions

Metformin DRUG

Only obese children with insulin resistance were treated with metformin.

obesity

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Body mass index (BMI) \> 95th percentile
• Having insulin resistance
• Having a family history of Type 2 diabetes mellitus (T2DM)

You may not qualify if:

• Alcohol consumption and smoking
• Having T1DM and T2DM
• History of drug use

Sponsors & Collaborators

• HÜMEYRA ACIKAN: lead

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance; Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research asistant

Model Details: 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 Record Dates

• First Submitted: February 11, 2024
• First Posted: February 20, 2024
• Study Start: November 17, 2019
• Primary Completion: August 20, 2021
• Study Completion: October 27, 2021
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

TU (1)