Evaluation of the Effect of a Lactobacillus Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease in Obese Subjects With Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from basal plasma lipopolysaccharide (LPS) at 12 weeks
研究概览
简要总结
The purpose of this study is the evaluation of the effects in obese patients with metabolic syndrome on the composition of the intestinal microbiota, markers of the syndrome (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic steatosis) and other possible metabolites involved.
详细描述
Randomized double blind crossover placebo controlled intervention study
The proposed study will be conducted by members of the Endocrinology and Nutrition Services (ENCHJ), and Gastroenterology (ADCHJ), of the Hospital of Jaen and members of the Department of Biochemistry and Molecular Biology II of the University of Granada (UGR) and members of Microbiology Department of the University Hospital San Cecilio of Granada (MHUSC).
The selection, clinical and anthropometric control, general biochemical parameters and the determination of hepatic steatosis by ultrasound will be performed by members of ENCHJ.
The determination of the composition of the intestinal microbiota will be carried out by members of the UGR together with members form the MHUSC. Inflammation and steatosis biomarkers as well as metabolic profile will be performed by members of the UGR.
The study will be conducted according to the Helsinki Rules and will be previously approved by the Ethics Committee of Research of Jaen. The study will follow the rules of international, national and regional research The biological samples will be managed and processed in accordance with the research protocols by the Biobanco del Sistema Sanitario Público de Andalucía. At the end of the project, samples will be stored within the framework of Biobank from Public Health Organization of Andalusia .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of insulin resistance syndrome, according to Criteria of the International Diabetes Federation (IDF)
- •BMI>30 kg/m2 or Waist Circumference ≥ 94cm (men) WC≥ 80cm (women)
- •Serum Triglycerides ≥ 150 mg/dl
- •HDLcholesterol < 40 mg/dl (1,03 mmol/l) in men and < 50 mg/dl (1,29 mmol/l) in women
- •Systolic blood pressure ≥ 130 mmHg or diastolic ≥ 85 mmHg
- •Glucose ≥ 100 mg/dl (5,6 mmol/l) (not previous diagnostic of diabetes II)
排除标准
- •Patients with renal or hepatic impairment
- •Patients with a diagnosis of diabetes
- •Patients with diseases that condition immunosuppression
- •Patients presenting positive serologies for liver viruses
- •Being on antihypertensive treatment: beta-blockers, Angiotensin 2 receptor antagonists (ARA 2), enzyme inhibitors, Angiotensin converting enzyme (ACE) inhibitors.
- •Patients receiving lipid-lowering and / or hypoglycemic agents
- •Patients on treatment with drugs that increase hepatic enzymes,such as Amiodarone, perhexiline, maleate and 4,4'-diethylaminoethoxyhexestrol, synthetic estrogens, Tamoxifen, corticosteroids, acetylsalicylic acid, Valproic acid, tetracyclines, viral agents (zidovudine, zalcitabine, didanosine), among others.
- •Exhibiting high values of C-reactive protein (CRP) or Sedimentation (ESR)
- •Consuming alcohol in quantities greater than 40 g / d or other hepatotoxic.
结局指标
主要结局
Change from basal plasma lipopolysaccharide (LPS) at 12 weeks
时间窗: Basal (T0), 12 weeks
次要结局
- Change from basal plasma cholesterol level (total, LDL and HDL) at 12 weeks(Basal (T0), 12 weeks)
- Change from basal plasma Inflammatory markers (sVCAM, sICAM, myeloperoxidase selectin, adiponectin, plasminogen activator inhibitor and resistin, and interleukines Il-6, Il-8, tumor necrosis factor, HGF, leptin and Multicopper oxidase-1) at 12 weeks(Basal (T0), 12 weeks)
- Change from basal Blood pressure at 12 weeks(Basal (T0), 12 weeks)
- Change from basal HOMA ( homeostatic model assessment ) index at 12 weeks(Basal (T0), 12 weeks)
- Change from basal Hepatic Steatosis markers (arginase, prolidase and RBP-4(Retinol binding protein-4)) at 12 weeks(Basal (T0), 12 weeks)
- Changes from basal fecal microbiota at 12 weeks(Basal (T0), 12 weeks)