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The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial.

ABSTRACT: Background. In a recent randomized controlled trial (RCT) in obese adolescents, 18 month-treatment with metformin versus placebo was reported to lead to stabilisation of the BMI. This study aimed to compare the effect of metformin on BMI in obese adolescents in daily practice versus results obtained in an RCT. Methods. Obese adolescents treated off label with metformin in daily practice in an outpatient clinic with a follow-up of ?18 months were identified. Anthropometric and biochemical data were collected at baseline and at 18 months. Patients treated with metformin for 18 months in an RCT were used for comparison. BMI was compared between the two groups. Results. Nineteen patients (median age 14.3 (interquartile range 11.7-15.7) years, BMI 31.3 (28.8-33.8)?kg/m2) treated in daily practice were compared to 23 patients receiving metformin in the RCT (age 13.6 (12.6-15.3) years, BMI 29.8 (28.1-34.5)?kg/m2). BMI change after 18 months was -0.36 (-2.10-1.58) versus +0.22 (-2.87-1.27)?kg/m2 for the two groups, respectively. In the multivariable model, BMI change was not statistically significantly different between the two groups (p = 0.61). Conclusion. Treatment with metformin in obese adolescents in daily practice resulted in a comparable change in BMI as observed in an RCT. This trial is registered with ClinicalTrials.gov number: NCT01487993.

SUBMITTER: van der Aa MP

PROVIDER: S-EPMC5214571 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial.

van der Aa Marloes P MP Hoving Vera V van de Garde Ewoudt M W EM de Boer Antonius A Knibbe Catherijne A J CA van der Vorst Marja M J MM

Journal of obesity 20161222

<i>Background</i>. In a recent randomized controlled trial (RCT) in obese adolescents, 18 month-treatment with metformin versus placebo was reported to lead to stabilisation of the BMI. This study aimed to compare the effect of metformin on BMI in obese adolescents in daily practice versus results obtained in an RCT. <i>Methods</i>. Obese adolescents treated off label with metformin in daily practice in an outpatient clinic with a follow-up of ≥18 months were identified. Anthropometric and bioch ...[more]

PMID: 28101379

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Project description:Childhood obesity is a serious health concern affecting over 155 million children in developed countries worldwide. Childhood obesity is associated with significantly increased risk for development of type 2 diabetes, cardiovascular disease and psychosocial functioning problems (i.e., depression and decreased quality of life). The two major strategies for management of obesity and associated metabolic abnormalities are lifestyle modification and pharmacologic therapy. This paper will provide the background rationale and methods of the REACH childhood obesity treatment program.The REACH study is a 2-year multidisciplinary, family-based, childhood obesity treatment program. Seventy-two obese adolescents (aged 10-16 years) and their parents are being recruited to participate in this randomized placebo controlled trial. Participants are randomized to receive either metformin or placebo, and are then randomized to a moderate or a vigorous intensity supervised exercise program for the first 12-weeks. After the 12-week exercise program, participants engage in weekly exercise sessions with an exercise facilitator at a local community center. Participants engage in treatment sessions with a dietitian and social worker monthly for the first year, and then every three months for the second year. The primary outcome measure is change in body mass index and the secondary outcome measures are changes in body composition, risk factors for type 2 diabetes and cardiovascular disease, changes in diet, physical activity, and psychosocial well-being (e.g., quality of life). It is hypothesized that participants who take metformin and engage in vigorous intensity exercise will show the greatest improvements in body mass index. In addition, it is hypothesized that participants who adhere to the REACH program will show improvements in body composition, physical activity, diet, psychosocial functioning and risk factor profiles for type 2 diabetes and cardiovascular disease. These improvements are expected to be maintained over the 2-year program.The findings from this study will advance the knowledge regarding the long-term efficacy and sustainability of interventions for childhood obesity.ClinicalTrials.gov number NCT00934570.

Dataset Information

The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial.

Publications

The Effect of Eighteen-Month Metformin Treatment in Obese Adolescents: Comparison of Results Obtained in Daily Practice with Results from a Clinical Trial.

Similar Datasets

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