Skip to main content

Table 1 Inclusion and exclusion criteria

From: METFORMIN: an efficacy, safety and pharmacokinetic study on the short-term and long-term use in obese children and adolescents – study protocol of a randomized controlled study

Inclusion criteria

Exclusion criteria

Age: 10–16 years

Presence of T2DM, polycystic ovarian syndrome, or endocrine disorders treated with corticosteroids

Obesity defined as BMI standard deviation score >2.3

Height <-1.3 SD of target height

Insulin resistance defined as HOMA-IR ≥3.4

Syndromal disorders with or without mental retardation

Caucasian descent

Pregnancy

Informed consent signed by parents and participant

Use of anti-hyperglycaemic drugs, ritonavir or ACE-inhibitors

 

(History of) alcohol abuse

 

Impaired renal or hepatic function (renal function defined as glomerular filtration rate (GFR) <80 ml/min; GFR = 40 × length (cm)/serum creatinine (μmol/l); hepatic function: alanine aminotransferase >150% of normal value for age)

 

Insufficient knowledge of Dutch language