Pilot Study Fatty Liver and Obesity: MR Fat Quantification and MR Elastography During a Very Low-calorie-ketogenic Diet (Pronokal Method®) Versus a Low Calorie Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Liver fatty infiltration at 6 months
研究概览
简要总结
Prospective, multicenter, open-label, randomized and controlled study of the effects of weight loss and reduced visceral fat on non-alcoholic fat infiltration into liver after a very low calorie ketogenic diet (VLCK diet) (Pronokal® Method) versus a hypocaloric diet, with a 6-month follow-up.
详细描述
The investigators will include obese patients with BMI higher than 30 kg / m2 to follow a standardized multidisciplinary weight-loss program (PronoKal® Method), which consists of a very-low-calorie diet, into which natural foods are gradually reintroduced, accompanied by physical exercise and emotional support, versus hypocaloric diet.
The aim of this study are see the reduction of fatty liver, visceral fat and improvement of hepatic stiffness during the weight loss treatment.
Patients will be visited monthly and data will recorded on 4 occasions: pre-inclusion, initial visit, 2-months visit (end of ketosis) and 6-months visit.
Hepatic fatty infiltration and visceral fat will be scanned by MRI and hepatic stiffness will be assessed by MR Elastography at: baseline, 2 months and 6 months. Also will be recorded anthropometric data (weight, BMI, waist circumference) and complete blood tests.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex, older than 18 years
- •Obese patients with BMI equal or over 30kg/m2
- •Patients who agree to participate and sign the Informed Consent
排除标准
- •Pregnant or lactating women.
- •Patients weighing over 140 kg (by limitation of the MRI device)
- •Patients on anti-obesity drugs (eg, sibutramine, orlistat and liraglutide) or weight-interfering medications (eg, topiramate). In such cases a wash out period of 3 months is required.
- •Patients with alcohol intake > 20 g/day in women and > 30 g/day in men.
- •Patients with liver failure or with pathologies that may affect the liver
- •Patients with other causes of liver steatosis: chronic viral hepatitis and/or drug intake (corticosteroids, estrogens, NSAIDs, calcium antagonists, amiodarone, tamoxifen, tetracyclines, chloroquine, antiretrovirals, perhexiline).
- •Patients with eating disorders.
- •Patients with any psychiatric disorder (eg schizophrenia, bipolar disorder, substance abuse, severe depression).
- •Patients receiving dicumarinic anticoagulants (Sintrom®).
- •Patients taking corticosteroids.
- •Patients with severe kidney failure (gfr <30).
- •Patients with type 1 and type 2 diabetes mellitus.
- •Patients with hemopathies, including coagulation disorders
- •Patients with cardiovascular or cerebrovascular disease (of heart rate disorders, recent infarction [<6m], unstable angina, decompensated heart failure, recent stroke [<6m]).
- •Patients in acute attack of gout.
- •Patients with renal lithiasis verified by ultrasound.
- •Patients with cholelithiasis verified by ultrasound.
- •Patients with electrolyte imbalance, according to medical criteria.
- •Patients with orthostatic hypotension.
- •Patients with cancer or history of cancer who have not been discharged from oncology
- •Patients who are not expected to attend follow-up visits
结局指标
主要结局
Liver fatty infiltration at 6 months
时间窗: 6 months
Liver fatty infiltration percentage, measured by a MRI technique of fat liver quantification, fat at the end of treatment
次要结局
- Liver fatty infiltration at 2 months(2 months)
- Visceral fat at 2 months(2 months)
- Visceral fat at 6 months(6 months)
- Liver stiffness at 2 months(2 months)
- Liver stiffness at 6 months(6 months)
- Size of adrenal gland at 2 months(2 months)
- Size of adrenal gland at 6 months(6 months)
- Body Weight loss at 2 months(2 months)
- Body Weight loss at 6 months(6 months)
- Salivary cortisol levels at 2 months(2 months)
- Salivary cortisol levels at 6 months(6 months)