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

IVERSITA` DI TORINO0 个研究点目标入组 320 人开始时间: 2010年12月22日最近更新: 2019年2月28日

适应症

试验速览

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•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 : 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

发起方

IVERSITA` DI TORINO