se of metformin in obese adolescent patients - Metformin in obese adolescents

Phase 1

• Conditions: Obesity; MedDRA version: 9.1 Level: SOC Classification code 10027433; MedDRA version: 9.1 Level: HLGT Classification code 10003018; MedDRA version: 9.1 Level: HLT Classification code 10018067; MedDRA version: 9.1 Level: PT Classification code 10029883

• Registration Number: EUCTR2010-022815-21-IT
• Lead Sponsor: IVERSITA` DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

Caucasian subjects of both sexes, between 10 and 16 years of age. Inclusion Criteria: 1) BMI higher or equal to 95? percentile for sex and age; 2) HOMA-IR higher or equal to 2,5 in pre-pubertal patients and 4 in pubertal patients 3) HDL cholesterol inferior or equal to 40 mg/dl, or triglycerides higher or equal to 150 mg/dl, or systolic pressure higher or equal to 130 mmHg, or diastolic pressure higher or equal to 85 mmHg.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria : 1) Type 1 or 2 Diabetes Mellitus 2) Contraindications to the use of metformin (renal disease or dysfunction, congestive heart failure requiring pharmacologic treatment, known hypersensitivity to metformin, acute or chronic metabolic acidosis) 3) Endocrine, liver diseases 4) Ongoing therapies for chronic systemic diseases 5) Patients at risk of pregnancy or lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using a contraception method. 6) Lactose intolerance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether changes in BMI and one or more additional cardiovascular risk factors (waist circumferance, HOMA-IR, HDL cholesterol, triglycerides, arterial blood pressure) occur during and/or after metformin treatment in insulin-resistant obese patients aged 10 to 16 years.;Secondary Objective: To evaluate whether changes in cytokine levels during and/or after metformin therapy occur in insulin-resistant obese patients aged 10 to 16 years. This will clarify the role of cytokines in the obesity-related insulin resistance.;Primary end point(s): Variation of BMI and of prevalence of one or more additional cardiovascular risk factors (waist circumference, HOMA-IR, glucose, HDL cholesterol, triglycerides, arterial blood pressure) during and/or after metformin.