Inflammatory Mediators in Obese Adolescents With Insulin Resistance Following Metformin Treatment: Controlled Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Adiponectin
研究概览
简要总结
The purpose of this study is to compare serum concentrations of inflammatory cytokines, interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese adolescents with insulin resistance (IR).
详细描述
The increased prevalence of obesity in pediatric patients is a public health problem particularly because of the difficulties involved with changing lifestyles. Current studies of obese children and adolescents show increased insulin resistance (IR) and chronic inflammatory states. These conditions increase the risk of disability and/or premature death.
The current treatment schemes for obese children are conservative and are focused on changing their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR, dyslipidemia, and inflammatory processes, are perpetuated.
Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have observed decreases in IR, decreases in weight, and improvements in lipid metabolism.
Adipose tissue is not only an energy repository, but also plays an immunological role by the secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered to be a risk marker for the development of cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity defined as Body Mass Index (BMI) ≥ percentile 95
- •Tanner stage ≥ 2
- •Insulin resistance defined as Basal insulin > 15 µU/mL or Homeostasis Model Assessment index (HOMA) > 4.5
- •Patients' parents signed written consents when they and their adolescent children agreed to enroll
排除标准
- •Glucose intolerance
- •Diabetes mellitus (type 1 or 2)
- •Anemia (Hb < 10 g/dL)
- •Plasma creatinine > 1.4 mg/dL
- •Abnormal hepatic function
- •Any associated Disease (Pulmonary, Infection, Autoimmune Disease)
- •History of lactic acidosis
研究组 & 干预措施
Placebo
Tablet of 500 mg oral placebo every 12 hours for 3 months.
干预措施: Placebo (Drug)
Metformin
Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
干预措施: Metformin (Drug)
结局指标
主要结局
Adiponectin
时间窗: baseline and 3 months
Change from baseline in Adiponectin after 3 months of treatment.
High-sensitivity C-reactive Protein
时间窗: baseline and 3 months
Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.
Interleukin 6
时间窗: baseline and 3 months
Change from baseline in Interleukin 6 after 3 months of treatment.
Tumour Necrosis Factor Alpha
时间窗: baseline and 3 months
Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.
次要结局
- Fasting Plasma Glucose(baseline and 3 months)
- Fasting Insulin(baseline and 3 months)
- Body Mass Index(baseline and 3 months)
- Waist Circumference(baseline and 3 months)
研究者
Maria Lola Evia-Viscarra
Pediatrics Endocrinology
Hospital Regional de Alta Especialidad del Bajio