Controlled Clinical Trial of the Effect of Cocoa Consumption in Patients With Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Changes in the insulin resistance index (HOMA-IR)
研究概览
简要总结
Metabolic syndrome (MS) is a clinical entity that includes several disorders that predispose to imbalance in lipid metabolism: hypertension, insulin resistance, hypertriglyceridemia, obesity and low levels of high density lipoprotein. The SM itself has a great impact on morbidity and mortality and is also related to increased cerebrovascular risk and Diabetes Mellitus 2 (DM2). In Colombia, DM2 is one of the 10 leading causes of illness and death in people over 45 years. It is accepted that insulin resistance is a stage that precedes the onset of DM2, but there are few alternatives to reverse it or prevent its progression to diabetes.
The control of insulin resistance requires increased physical activity, reduced body weight and changes in eating patterns, measures that are not easily adopted in modern Western society.
There is evidence of the effect of chocolate consumption on increasing insulin sensitivity in both hypertensive diabetic patients as well as in normal individuals, apparently because of the ability of cocoa polyphenols to increase the bioavailability of nitric oxide, Formation of reactive species of oxine, optimizing carbohydrate metabolism and modulating insulin-related cellular signaling events.
A prospective, double-blind, placebo-controlled, double-blind clinical trial evaluating the effect of 50 g of chocolate with 70% cocoa solids, which contributes at least 430 mg of polyphenols, is conducted for 8 weeks in The reduction of insulin resistance defined by the reduction of the HOMA-IR index. In addition, there was an increase in arterial reactivity in non-diabetic individuals with central obesity and insulin resistance. Likewise, to infer the effect of this food intervention in the modification of the total cardiometabolic risk of the participants.
详细描述
RATIONALE Metabolic syndrome (MS) is a clinical entity associated with obesity, insulin resistance (IR), hypertension, hypertriglyceridemia and low HDL. This syndrome promotes the pathophysiological mechanisms of oxidative stress damage, endothelial inflammation, hypercoagulability, atheromatosis and metabolic dysfunction.
In Colombia, morbidity and mortality from chronic diseases related to MS, such as arterial hypertension and type II diabetes mellitus (DM2) represent high costs to the health system due to the direct attention of these diseases as well as their more frequent complications: acute myocardial infarction, cerebrovascular disease, peripheral neuropathy, retinopathy and renal failure. In addition to social costs due to incapacity for work, loss of years of useful life and reduction in the quality of life of patients and their families.
IR biologically precedes the development of DM2 and some authors propose that it is one of the initial manifestations of MS. It is estimated that 25% of individuals with IR will develop DM2 within 3 to 5 years and 50% will retain their IR status. In the global context, it is estimated that in 2010 approximately 344 million people between the ages of 20 and 79, or 7.9% of the population, are estimated to reach 472 million in 2030, that is, 8.4 million of the adult population with the aggravation that the majority will be located in middle to low income countries.
Despite the relevance of IR in the pathophysiology of DM2, since it is its previous stage, there is no public health policies aimed at conducting an active search for the cases and in the event that the diagnosis is made, there are few alternatives to reverse it or prevent its progression to diabetes. Control of IR demands interventions in people's lifestyles such as increased physical activity, reduced body weight and changes in eating patterns, however, despite the effectiveness of these measures, its real impact is low since it involves drastic modifications in the habits of consumer life that characterize modern Western society.
Grassi et al demonstrated in a short-term (15-day) clinical study that the consumption of black chocolate, as opposed to white chocolate, reduces blood glucose and modulates the mean arterial flow in hypertensive patients who have IR.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abdominal circumference greater than 80 cm in women and greater than 90 cm in men
- •HOMA [basal insulin x basal glycemia] / 22.5 equal to or greater than 2.5
- •Basal glycemia normal or compatible with carbohydrate intolerance (baseline glycemia less than 126 mg / dL).
- •Disposition for the consumption of chocolate.
- •Acceptance and signing of informed consent
排除标准
- •Usual consumption of 50 g or more grams of chocolate three or more times per week
- •Insulin application, consumption of metformin or any other hypoglycemic substance.
- •Surgical history of gastric resection
结局指标
主要结局
Changes in the insulin resistance index (HOMA-IR)
时间窗: Baseline and 8 weeks
Changes HOMA-IR
次要结局
- Anthropometric measurement 1(8 weeks)
- Anthropometric measurement 2(8 weeks)
- Anthropometric measurement 3(8 weeks)
- SF-36 Questionnaire of Quality of life(8 weeks)
