The LIFE-MET trial: effect of insulin sensitization on pubertal progression following lifestyle intervention and/or treatment with metformin in girls with early puberty and overweight: study protocol for a randomized, placebo-controlled trial
Abstract
Background: Puberty in girls is occurring earlier worldwide with a declining trend over the recent decades, resulting in increased attention on the accompanying risks of psychosocial challenges and adverse health outcomes for the affected girls. Diverse mechanisms have been proposed as mediators of the tendency for earlier pubertal maturation, including a shift toward a more sedentary lifestyle and changes in dietary habits leading to childhood obesity. Several studies have demonstrated a potential association between the rise in childhood obesity prevalence and the decline in the age at which puberty begins. Increased insulin resistance is thought to play a role in this connection, and previous studies indicated that improved insulin sensitivity following either treatment with metformin or weight loss could delay pubertal progression in girls with overweight.
Methods: LIFE-MET is a randomized, placebo-controlled, four-arm, multicenter trial of girls (n = 80) with overweight and early puberty. Allocation to metformin or placebo will be double-blinded. Eligible girls will be randomly assigned to one of the four study arms: Metformin + lifestyle intervention (N = 20), Metformin alone (N = 20), Placebo + lifestyle intervention (N = 20), Placebo alone (N = 20). The intervention period is 6 months with a follow-up after an additional 6 months. The primary outcome is the change in bone age from baseline to 12 months, as a marker of pubertal progression. Secondary outcomes include…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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