NCT03530566Unknown不适用
Prospective Comparative Clinical Study to Evaluate Effectiveness of a Standardized Multidisciplinary Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery
Protein Supplies SL0 个研究点目标入组 25 人开始时间: 2018年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 主要终点
- Body weight loss at 3 monthes
研究概览
简要总结
Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery.
详细描述
Study population: 25 patients with morbid obesity (BMI ≥ 40 kg / m2) or severe obesity (BMI 35 to 39.9 kg / m2) , with two or more comorbidities, scheduled for bariatric surgery within 3 months, and who will start treatment with the multidisciplinary weight loss program (PnK Method) based on diet, exercise and psychological support.
Patients will be followed-up for 3 months, with the following controls: pre-selection, baseline, month 1, month 2, month 3, and control when hospital discharge.
The treatment schedule in these patients will be as follows: a very low calorie ketogenic diet for at least 1 month or until losing 10% of the weight, and then, a low calorie diet with gradual reintroduction of natural foods for 2 months, until surgery.
The investigators will obtain retrospective data from 25 patients treated with the standard diet who met the same inclusion/exclusion criteria as the patients in this study and who similarly resemble in age, sex and BMI, for comparative analysis (control group).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 of both sexes, between 18 and 65 years old
- •Patients with morbid obesity (BMI ≥ 40 kg/m2) or with severe obesity (BMI 35 to 39.9 kg/m2), with two or more comorbidities associated with obesity (type 2 diabetes mellitus, arterial hypertension, obstructive sleep apnea, obesity hypoventilation syndrome, chronic respiratory disease, metabolic syndrome, atrial fibrillation, heart failure, pulmonary hypertension, cardiomyopathy, history of thrombosis, renal failure).
- •Patients scheduled for bariatric surgery within 3 months ± 1 week.
- •Patients who, regardless of their inclusion in this study, will undergo treatment with the multidisciplinary slimming program in study or standard diet.
- •Patients who agree to participate and sign the Informed Consent
排除标准
- •Pregnant or lactating women.
- •Patients with type 1 diabetes mellitus or on insulin therapy
- •Patients with eating disorders, alcoholism, and/or drug addiction.
- •Patients with any severe psychological disorder (eg schizophrenia, bipolar disorder).
- •Patients receiving dicumarinic anticoagulants (Sintrom®) or cortisone.
- •Patients with liver failure.
- •Patients with severe kidney failure (gfr <30).
- •Patients with hemopathies.
- •Patients with cancer.
- •Patients with cardiovascular or cerebrovascular disease (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 depression.
- •Patients with electrolyte imbalance, according to medical criteria.
- •Patients with orthostatic hypotension.
- •Patients with contraindications to surgery
结局指标
主要结局
Body weight loss at 3 monthes
时间窗: from baseline to 3 monthes
Change in body weight from baseline to 3 monthes
次要结局
- Body weight loss at 2 monthes(from baseline to 2 monthes)
- Body weight loss at 1 month(from baseline to 1 month)
- Change in systolic blood pressure at 3 monthes(from baseline to 3 monthes)
- Change in diastolyc blood pressure at 2 monthes(from baseline to 2 monthes)
- Change in diastolic blood pressure at 3 monthes(from baseline to 3 monthes)
- Change in systolic blood pressure at 2 monthes(from baseline to 2 monthes)
- Change in systolic blood pressure at 1 month(from baseline to 1 month)
- Change in diastolic blood pressure at 1 month(from baseline to 1 month)
- Change in blood glucose at 3 monthes(from baseline to 3 monthes)
- Change in blood glucose at 2 monthes(from baseline to 2 monthes)
- Change in blood glucose at 1 month(from baseline to 1 month)
- Change in HbA1c at 3 monthes(from baseline to 3 monthes)
- Change in HbA1c at 2 monthes(from baseline to 2 monthes)
- Change in HbA1c at 1 month(from baseline to 1 month)
- Change in total cholesterol level at 1 month(from baseline to 1 month)
- Change in total cholesterol level at 3 monthes(from baseline to 3 monthes)
- Change in total cholesterol level at 2 monthes(from baseline to 2 monthes)
- Change in triglycerides level at 3 monthes(from baseline to 3 monthes)
- Change in triglycerides level at 2 monthes(from baseline to 2 monthes)
- Change in triglycerides level at 1 month(from baseline to 1 month)
- Metabolic Control of type 2 Diabetes at 3 months(from baseline to 3 monthes)
- Clinical Control of Hypertriglyceridemia at 3 months(from baseline to 3 monthes)
- Improvement of Sleep Apnea Obstructive Syndrome at 3 months(from baseline to 3 monthes)
- Clinical Control of arterial hypertension at 3 months(from baseline to 3 monthes)
- Clinical Control of Hypercholesterolemia at 3 months(from baseline to 3 monthes)
- Improvement of Chronic Respiratory Disease at 3 months(from baseline to 3 monthes)
- Improvement of Obesity hypoventilation syndrome at 3 months(from baseline to 3 monthes)
- Improvement of Metabolic syndrome at 3 months(from baseline to 3 monthes)
- Improvement of Atrial fibrillation at 3 months(from baseline to 3 monthes)
- Improvement of Cardiac insufficiency at 3 months(from baseline to 3 monthes)
- Improvement of Pulmonary hypertension at 3 months(from baseline to 3 monthes)
- Length of anesthesia(During bariatric surgery)
- Number of patients with intraoperative complications(During bariatric surgery)
- Number of patients with postoperative complications after bariatric surgery(After bariatric surgery)
- Number of total days of hospitalization(After bariatric surgery)
- Improvement of Cardiomyopathy at 3 months(from baseline to 3 monthes)
- Improvement of Renal insufficiency at 3 months(from baseline to 3 monthes)
- Obesity Surgery Mortality Risk Score(3 months)
- Length of surgery(During bariatric surgery)
- Number of Participants With Adverse Events related to preoperative weight loss treatment(Through 3 months of study)
- Number of weight loss treatment dropout rate(from baseline to 3 monthes)
- Number of patients who refuse bariatric surgery at 3 months(from baseline to 3 monthes)
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