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Published on: February 28, 2013
Does metformin improve vascular health in children with type 1 diabetes? Protocol for a one year, double blind,
Insights
This study investigates metformin
Area of Science:
- Pediatric Endocrinology
- Cardiovascular Research
- Metabolic Disorders
Background:
- Cardiovascular disease (CVD) is the primary cause of death in children with Type 1 diabetes (T1D).
- Vascular dysfunction is an early indicator of CVD in T1D, necessitating early interventions.
- Metformin, an insulin-sensitizing drug, shows promise for improving vascular health, with a proven safety record in pediatric Type 2 diabetes.
Purpose of the Study:
- To assess the efficacy of metformin in improving vascular health among children diagnosed with Type 1 diabetes.
- To evaluate metformin's impact on key vascular and biochemical markers in this pediatric population.
Main Methods:
- A 12-month, double-blind, randomized, placebo-controlled trial involving 76 children (ages 8-18) with T1D.
- Participants were divided into two groups: 38 receiving metformin and 38 receiving a placebo.
- Vascular health was assessed using flow-mediated dilation, glyceryl trinitrate-mediated dilation, and intima-media thickness measurements at baseline and at 3, 6, and 12 months.
Main Results:
- Data collection and analysis are ongoing.
- Interim results will be presented upon completion of the 12-month study period.
Conclusions:
- This trial is the first to examine metformin's effects on vascular health in children with T1D.
- Findings are expected to provide crucial insights into a potential therapeutic strategy for reducing cardiovascular risk in this high-risk group.
Background:
Cardiovascular disease is the leading cause of mortality in Type 1 diabetes (T1D). Vascular dysfunction is an early and critical event in the development of cardiovascular disease. Children with T1D have vascular dysfunction therefore early interventions to improve vascular health are essential to reduce cardiovascular mortality in T1D. Metformin is an insulin sensitising agent which is known to improve vascular health outcomes in type 2 diabetes (T2D) and other individuals with insulin resistance. It has been used safely in children and adolescents with T2D for over 10 years. This study aims to assess the effect of metformin on vascular health in children with T1D.
Methods/Design:
This study is a 12 month, double blind, randomised, placebo controlled trial to determine the effect of metformin on vascular health in children (age 8-18) with T1D. The sample size is 76 with 38 children in the metformin group and 38 children in the placebo group. Vascular health and biochemical markers will be measured at baseline, 3, 6 and 12 months. Vascular function will be measured using flow mediated dilatation and glyceryl trinitrate mediated dilatation of the brachial artery and vascular structure will be measured with carotid and aortic intima media thickness, using standardised protocols.
Discussion:
This study will be the first to investigate the effect of metformin on vascular health in children with T1D. It will provide important information on a potential intervention to improve cardiovascular morbidity and mortality in this population at high risk from cardiovascular disease.
Trial Registration:
Australia New Zealand Clinical Trials Registry ACTRN12611000148976.
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