Effect of Administration of Combination Metformine/Inulin Versus Metformine on Patients With Prostate Benign Hyperplasia and Metabolic Syndrome Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- International Prostate Symptom Score (I-PSS)
研究概览
简要总结
Type 2 diabetes mellitus, insulin resistance, visceral obesity and disorders of lipid metabolism, especially triglyceride and hypertension are metabolic disorders that play a central role in pathophysiology of metabolic syndrome, and ultimately, the cardiovascular morbidity and mortality associated with atherosclerosis, such as myocardial infarction, cerebral vascular events, vascular dementia, heart failure and end stage renal disease. Recently other complications related with hyperinsulinemia like the prostate benign hypertrophy (BPH). Metformin is the treatment of choice in patients with metabolic syndrome, given its low cost and comparable pharmacological effects to the tiazolinedionas (eg pioglitazone), decreasing hyperinsulinemia, insulin resistance, concentration of free fatty acids and triglycerides, also it produces moderate weight loss, improving the metabolic profile triglcerides atherogenic lipid and carbohydrate and delaying the onset of diabetes mellitus in individuals with impaired fasting glucose.
A second option for risk reduction would be the addition of inulin fiber type as it has been demonstrated some metabolic effects on benefices lipid metabolism and carbohydrate.
It is expected that combination of metformin with inulin produce a beneficial effect through farmacological synergism and the impact on fisiopatological changes of metabolic syndrome that potentially is considered as an important risk factor for prostate growth.
详细描述
The main objective is to evaluate the effect of the combination of metformin / inulin on clinical, urodynamic parameters as well as metabolic and inflammatory profile in patients with benign prostate hypertrophy and metabolic syndrome.
The investigators conducted a double-blind trial, randomized, on 4 groups, each group with 15 male and female patients of 40 to 80 years of age with METS diagnosed by IDF criteria and clinical diagnose of HBP. Randomization will determine who will receive the intervention during 12 week trial, each group will be like:
Group (A) intervention with combination metformin/ inulin: 15 individuals recieved combination of metformin/ agave inulin in a dosis of 500 mg / 10 grs per 24hrs during 12 weeks.
Group (B) Metformin plus Placebo of agave inulin: 15 individuals recieved Metformin in a dosis of 500mg per day (with the first bite of the second meal) plus homologue placebo of agave inulin (calcinated magnesia) in a dosis of 10grs each 24 hrs during 12 weeks.
Group (C) agave inulin plus placebo of Metformin: 15 indivuduals recieved agave inulin in a dosis of 10grs per 24hrs plus homologate placebo of metformin (calcinated magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 12 weeks.
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, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metabolic syndrome by IDF criteria
- •a person to be defined as having the metabolic syndrome they must have: Central obesity (defined as waist circumference* with ethnicity specific values) ≥80 cm in females and ≥90 cm in males; and plus any two of the following four factors:
- •Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL cholesterol
- •< 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females or specific treatment for this lipid abnormality
- •Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
- •Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
- •Age ranging from 40 to 80 years old
- •Male patients
- •Informed written consent
排除标准
- •Kidney disease
- •Hepatic disease
- •Thyroid disease
- •Diabetes mellitus
- •Ischemic heart disease
- •Drug consumption
- •Alcohol consumption of more than 2 ounces daily
- •Consumption of drugs that intervene with lipid or glucose metabolism 2 months before
- •Blood pressure >160/100mmHg.
- •Lack of adherence to treatment (adherence <80%)
研究组 & 干预措施
Metformin + Placebo of agave inulin
500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder
干预措施: Metformin (Drug)
Agave inulin + Metfomin
5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs
干预措施: Metformin (Drug)
Agave inulin + Metfomin
5 g of Agave inulin powder every 12 hrs + 500 mg tablet of metformin every 24 hrs
干预措施: Agave inulin (Dietary Supplement)
Metformin + Placebo of agave inulin
500 mg tablet of metformin every 24 hrs + 5 g every 12 hrs of calcinated magnesia powder
干预措施: Placebo of agave inulin (Other)
Agave Inulin+Placebo of Metformin
5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs
干预措施: Agave inulin (Dietary Supplement)
Agave Inulin+Placebo of Metformin
5 g of agave inulin powder every 12 hrs + 500 mg tablet of calcinated magnesia as metformin placebo every 24 hrs
干预措施: Metformin placebo (Other)
Placebo of Inulin + Placebo of Metformin
5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs
干预措施: Placebo of agave inulin (Other)
Placebo of Inulin + Placebo of Metformin
5 g of calcinated magnesia powder every 12 hrs + 500 mg tablet of calcinated magnesia every 24 hrs
干预措施: Metformin placebo (Other)
结局指标
主要结局
International Prostate Symptom Score (I-PSS)
时间窗: 12 weeks
before and after intervention questionnaire
次要结局
- Change from baseline in Peripheral systolic blood pressure(12 weeks)
- Change of HOMA-IR from base line to 12 weeks(12 weeks)
- Change from Baseline in Fasting plasma glucose at 12 weeks(12 weeks)
- Change from Baseline in Total cholesterol at 12 weeks(12 weeks)
- Change of waist circumference(12 weeks)
- Change of body mass index(12 weeks)
- Change from baseline in High-density lipoprotein cholesterol at 12 weeks(12 weeks)
- Change from Baseline in Triglycerides at 12 weeks(12 weeks)
- Change from baseline in Peripheral diastolic blood pressure(12 weeks)
- qmax urine flow rate(12 weeks)
- prostate serum antigen(12 weeks)
研究者
Fernando Grover Paez
Fernando Grover-Paez, PhD
Centro Universitario de Ciencias de la Salud, Mexico