Off-label use of metformin in obese children and adolescents to reduce BMI-SDS– a retrospective study.

Hoving, V. (Vera) (2015) Off-label use of metformin in obese children and adolescents to reduce BMI-SDS– a retrospective study. thesis, Medicine.

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Abstract

Background: Childhood obesity is a worldwide increasing problem. Obesity is associated with various complications, both physical and psychological. Obese children and adolescents are also more at risk to become obese adults with morbidity and premature mortality. Currently, treatment for obesity focuses mainly on lifestyle intervention. Unfortunately, long-term success of lifestyle intervention alone is disappointing. For adults, it is already known that metformin could reduce BMI. Less is known about the effects of metformin on BMI-SDS in children and adolescents. Objective: To evaluate the effect of metformin on BMI-SDS in children (≥ 10 years) and adolescents with obesity (BMI-SDS ≥ 2.3) and insulin resistance (HOMA-IR ≥ 3.4) or type 2 diabetes mellitus (T2DM). Design: Retrospective cohort study. Participants: Children and adolescents aged from 10 to 18 years old were eligible if they were obese (defined as BMI-SDS ≥ 2.3), had insulin resistance (defined as HOMA-IR ≥ 3.4) or type 2 diabetes mellitus at times of screening and received treatment with metformin for at least six months. Subjects were excluded when they were diagnosed with diabetes mellitus type I. The study population consisted of two treatment arms: subjects who received metformin in clinical care (out-patient cohort) and subjects who received metformin in combination with lifestyle intervention in context of a running clinical trial and who finished the first part of this trial (RCT cohort)†. Methods: The medical files of obese children who visited the paediatric obesity out-patient clinic between 2006 and 2014 were identified by using DBC-code (‘Diagnose Behandeling Combinatie’, abbreviated to ‘DBC’ in Dutch) ‘adiposity’ and ‘diabetes’. Subjects who met the criteria were included. Data were analysed using IBM SPSS Statistics version 20.0. Primary outcome: BMI-SDS after 18 months of treatment with (off-label) metformin. Secondary outcome: Insulin resistance after 18 months of treatment with (off-label) metformin, BMI-SDS after 6 and 12 months of treatment and recorded adverse effects of metformin. Results: The total study population consisted of 32 subjects, of whom 15 were included in the out-patient cohort and 17 in the RCT cohort. There was a clinically significant reduction in BMI-SDS after 18 months of treatment in both groups (p <0.05). There was no difference between these two groups in BMI-SDS after 18 months (p=0.609). In contrast to the out-patient cohort, there was a significant reduction in insulin resistance after 18 months of treatment in the RCT cohort (p=0.008). However, there was no significant difference in insulin resistance between the two groups (p=0.099). Conclusion: Metformin is associated with a small, but clinically significant reduction in BMI-SDS after 18 months of treatment. The additional effect of lifestyle intervention on BMI-SDS appears to be negligible, although it may cause a decrease in insulin resistance.

Item Type:	Thesis (Thesis)
Supervisor name:	Brand, Prof. dr. P.L.P.
Supervisor name:	Vorst, Dr. M.M.J. van der and St. Antonius Hospital, Nieuwegein and the Netherlands
Faculty:	Medical Sciences
Date Deposited:	25 Jun 2020 10:42
Last Modified:	25 Jun 2020 10:42
URI:	https://umcg.studenttheses.ub.rug.nl/id/eprint/328

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