Efficacy and Safety of Nutraceuticals (Bergamot 450 mg, Gymnema (400 mg, Phaseolamin 30 mg, Olea Europaea 10 mg) in Patients With Diabetes Mellitus Type II and Dyslipidemia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- colesterol
研究概览
简要总结
The presence of dyslipidemia, is a significant cardiovascular risk factor. This factor, however, determines the three-fold increase in cardiometabolic risk when an isolated or mixed dyslipidemia is associated with the presence of diabetes mellitus. Diabetes mellitus is a metabolic alteration resulting in a decrease in insulin secondary to reduced availability of this hormone or an impediment to its normal action or a combination of these factors. . Under normal conditions, the vascular endothelium responds to short-term increases in flow by releasing NO and other endothelium-dependent relaxing factors that dilate the artery. Flow-mediated dilation(FMD) is impaired in atherosclerotic coronary arteries. The supplementation with polyphenols of olive leaves, bergamot extract, gymnema sylvatic extract (gymnemic acid) and phaseolamin (bean protein) significantly improves the glico-lipid balance through an improvement in liver function, an inhibition to more levels of lipid metabolism .
Recently, it has been documented how the polyphenolic fraction extracted from bergamot (BPF) administered orally both in animal models with induced hyperlipidemia diet, and in patients with metabolic syndrome, produces a significant and substantial reduction of serum cholesterol, triglycerides and blood levels of glucose. This effect was accompanied by an important improvement in vascular reactivity in patients with hyperlipidemia and high blood sugar, suggesting the potential protective role of BPF in patients with metabolic syndrome and elevated cardiovascular risk.
Oleuropeina (Olea Europaea) is also characterized by a peculiar polyphenolic profile. Both fruits and leaves, thanks to their cardioprotective activity, are used as antihypertensive agents and in the treatment of vascular disorders. The gymnemic acid (glycosidic triterpene), extracted from the leaves of Gymnema Sylvestre, is the representative element of the plant. Thanks to its presence in the phytocomplex, it carries out a hypoglycaemic action through two main mechanisms: inhibition of intestinal sugar absorption and increased metabolic transformation of glucose at the cellular level.
To better define the interrelations of systemic CRFs, FMD, and effects of chronic nutraceutical supplements we performed clinical evaluations and ultrasound measurements of the flow and diameter responses to forearm cuff occlusion in a large, well characterized community-based cohort.
详细描述
Primary end point Effectiveness To demonstrate in diabetic patients,the effectiveness of nutraceuticals (bergamot 450 mg, Gymnema (400 mg, Phaseolamin 30 mg, Olea Europaea 10 mg) to reduce total and LDL cholesterol.
Secondary end points To demonstrate in diabetic patients,the effectiveness of nutraceuticals (bergamot 450 mg, Gymnema (400 mg, Phaseolamin 30 mg, Olea Europaea 10 mg) to improve Endothelial function evaluated with vascular Doppler color echo; CHARACTERISTICS OF THE POPULATION diabetic patients in optimized medical therapy and increased plasma levels of total and LDL cholesterol EXPERIMENTAL DESIGN AND METHODOLOGY OF RESEARCH Experimental drawing Phase II prospective, randomized, comparative, vs placebo study Sample size Literature data show that total cholesterol levels> 200 mg / dl and LDL> 130 mg//dl have an increased cardiovascular risk in subjects with diabetes mellitus; in the Calabrian people the Health Examination Survey conducted in 2012, showed the following average values: total cholesterolemia 233 +/- 45 mg /dl for men and 238 +/- 40 mg / dl for women; while for LDL cholesterol the mean values are respectively 151 +/- 30 mg / dl in humans and 148 +/- 35 mg / dl in women. In these subjects the doubling of the statin dosage contributes to a further reduction of plasma levels by about 6%; the hypothesis not evaluated is that the integration with nutraceuticals (bergamot 450 mg, Gymnema (400 mg, Phaseolamin 30 mg, Olea Europaea 10 mg) in patients with optimized therapy, involves reduction of plasma levels> 6% HYPOTHESIS N =2(1600)/(196)*6,2= 3200/196*6.2= 88 The study will be performed with the enrollment of 88 diabetic patients, Eligible patients will be of both sexes, and naïve patients on nutraceutical (920 mg), consequently recruited.
Patients using randomization tab will be randomized 1: 1 to treatment with active substance versus placebo. Investigators may not be aware of the sequence in which the treatments will be assigned nor foresee the next assignment in any way.
TIMING OF THE STUDY The duration of the study will be 12 weeks after recruitment. After signing the informed consent, previously approved by the Ethics Committee, the subjects can fully enter the study. Each patient must make three visits: SEL (selection visit); V01 (initial visit); TERM (final visit). Excluding the patient's inclusion visit (V01), each visit will take place in the morning and each patient will be studied at the same time of day, between 8.00 am and 12.00 am, during the study (± 2 hours).
The treatment is always accompanied by main meals. The first administration in naïve patients on Nutraceuticals will be done under the supervision of the staff involved in the study. Patients will then be reviewed at 4 and 12 weeks after recruitment.
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
- 30 Years 至 —（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by the patient
- •Fasting plasma glucose ≥ 126 mg / dl (7 mmol / l);
- •Hypercholesterolemia (LDL cholesterol ≥ 130 mg / dl), with or without hypertriglyceridemia (> 175 mg / dl);
- •Medical therapy stabilized for 4 months. For women of reproductive age, enrolled in the study, the non-occurrence of pregnancy must be guaranteed.
- •All concomitant treatments should have started at least 3 months before the start of the study and should be kept at a constant dose throughout the study.
排除标准
- •Positive pregnancy test (βGCH), made at the selection visit (SEL) or in any case doubtful, pregnant women, lactating women, women of childbearing age who do not use estrogens or progestogens or intrauterine contraceptive methods;
- •Patients with severe gastrointestinal disorders with possible influence of the drug on electrolytes and absorption;
- •Patients with severe kidney disease (GFR 30 mL / min / 1.73 m2),
- •Patients with liver disease or obstructive disorders of the biliary tract, with or without complications (chronic hepatitis, cirrhosis, etc.), or with GOT or GPT at the upper limits of 3 times the laboratory reference values;
- •History of alcoholism or drug abuse;
- •Clinical history of serious illness that can in some way interfere with the conduct of the study, infections and neoplasms;
- •History of psychiatric disorders, major depression, or suicide attempts;
- •Patients with HIV or taking HIV medications
- •Presence of low-threshold myocardial ischemia
- •Presence of heart failure of class III and IV NYHA (New York Heart Association)
- •Patients with current infections
- •Valve prosthesis patients;
- •Patient with atrial fibrillation;
- •Patients with contraindication to physical exercise;
研究组 & 干预措施
placebo
placebo tablet twice a day twenty minutes before main meals, for 12 weeks,
干预措施: Placebo Oral Tablet (Drug)
nutraceutical oral capsule
nutraceutical oral capsule 920 mg twice a day for 12 weeks
干预措施: Nutriceutical Oral Capsule, (Drug)
结局指标
主要结局
colesterol
时间窗: "day 0" , "month 1", "month 3"
change cholesterol,
次要结局
- Endothelial function("day 0" , "month 3")
研究者
Capomolla Antonio
Division Director
Villa dei Gerani