Effects of Butyrate on Insulin Resistance in Children Affected by Obesity
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of insulin resistance
研究概览
简要总结
Butyrate is a short chain fatty acid (SCFA) produced by bacterial fermentation of undigested starch in the gut. Butyrate carries out different effects at intestinal and extraintestinal level, including: immune regulation with anti-inflammatory effect at intestinal and systemic level and modulation of gut microbiota. Many of these effects result from an epigenetic mechanism. Shown in an animal model of obesity induced by a high fat diet (HFD), that butyrate can exercise very effective protective action against obesity through the stimulation of intestinal satiety hormones. Shown always in murine model of obesity induced by HFD, that butyrate is effective in preventing and treating obesity and insulin resistance. After 5 weeks of treatment with butyrate was observed a reduction of 10.2% of body weight, 30% of fasting glucose and 50% insulin resistance.
In an animal model of metabolic syndrome with NAFLD researchers have recently demonstrated that the administration of butyrate is able to significantly reduce insulin resistance, liver damage, dyslipidaemia through a modulation of the inflammatory process.
Pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of butyrate is safe and well tolerated. The peak serum levels occurs 4-6 hours after oral administration.
All of these data makes plausible a possible positive effect on insulin resistance in the obese child.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity (BMI >95° percentile)
- •HOmeostasis Model Assessment (HOMA-IR) > 4 (obtained by calculating the product of fasting plasma insulin expressed in microunits/mL and fasting plasma glucose expressed in mmol/L divided by 22.5)
排除标准
- •Age <10 or >15 years
- •BMI <95° centile
- •HOMA-IR <4
- •Patients under pharmacological treatment for obesity (metformin) or taking vitamin E, pre-, pro- or synbiotics
- •Simultaneous presence of other chronic diseases unrelated to obesity (cancer, immunodeficiency, cystic fibrosis, allergies, celiac disease, autoimmune diseases, neuropsychiatric disorders, type 1 diabetes, inflammatory bowel diseases, malformations of urinary or gastrointestinal or respiratory tract, chronic lung diseases, genetic and metabolic diseases, chronic hematological diseases)
- •History of surgery for the treatment of obesity
- •Any medical condition that may interfere with participation in this study
- •Participation in other clinical trials still in progress
研究组 & 干预措施
Hypocaloric diet plus placebo
Hypocaloric diet plus placebo
干预措施: Placebo (Other)
Hypocaloric diet plus butyrate
Hypocaloric diet plus butyrate
干预措施: Butyrate (Dietary Supplement)
结局指标
主要结局
Reduction of insulin resistance
时间窗: After 6 months of treatment
次要结局
- Reduction of body weight(After 6 months of treatment)
研究者
Roberto Berni Canani
MD, PhD
Federico II University