The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Occurrence of recurrent acute pancreatitis and/or all-cause mortality
研究概览
简要总结
This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.
详细描述
Around 20% of patients with acute pancreatitis (AP) will go on to have acute recurrent pancreatitis (ARP) and 10% progress to chronic pancreatitis (CP). While interventions to avoid recurrences exist for the two most common causes - removal of the cholecyst in the case of biliary, and alcohol seccation in the case of alcoholic - a method to prevent idiopathic pancreatitis is not yet known. Although none of the guidelines suggest the administration of low fat diet, it is recommended by physicians to all pancreatitis patients are. Our aim is to conduct a randomized controlled trial, to assess the problem of dietary fat reduction on the recurrence of acute pancreatitis Patients, who had at least two acute pancreatitis episodes in the preceding 2 year will be approached to participate in the study and to either to be randomized to the 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) or to the 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations) group. During the 2 year long followup, participants will receive repeated dietary intervention at 3, 6, 12, 18, 24 months, they will completer food frequency questionnaires and their data regarding mortality, BMI, cardiovascular parameters and serum lipid values will be recorded The EFFORT trial will determine the effect of modified dietary fat content on the recurrence of AP, mortality, serum lipids and weight loss in idiopathic cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Doctors caring for the participants and assessors of all other outcomes (laboratory parameters, BMI, blood pressure, adverse events) as well as statisticians handling the data will be blinded to the participants' allocated group. Outcome assessors will be not avare of the allocated interventions.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with
- •The last episode being idiopathic, who are
- •Older than 14 years.
排除标准
- •Individuals already receiving regular nutritional guidance (with medical indication),
- •Individuals in critical condition or in terminal stage of cancer (with an expected survival <2 years) ,
- •Individuals undergoing treatment for active malignancy,
- •Individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy / HbA1c >6.5% / indication of uncontrolled diabetes mellitus in last 24 months' anamnesis / newly discovered diabetes mellitus)
- •Individuals with known cholecystolithiasis
- •Individuals who are pregnant or nursing
- •Individuals with a BMI < 18.5
- •Individuals who are regularly receiving systemic corticosteroids
- •Individuals consuming more alcohol than: 5 units per day or 15 units per week for men; 4 units per day or 8 units per week for women.
结局指标
主要结局
Occurrence of recurrent acute pancreatitis and/or all-cause mortality
时间窗: Data will be recorded during the 3-6-12-18-24 months followup visits
The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality.
次要结局
- Proportion of cardiosvascular cause mortality(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Proportion of newly diagnosed chronic pancreatitis patients(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Change in serum total cholesterol(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Serum high density liporpotein(HDL)-cholesterol(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Diastolic blood pressure(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Adherence to dietary recommendations as determined by the result of the food frequency questionnaire(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Adverse effects(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Change in vitamin D value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Change in vitamin E value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Serum low density liporpotein(LDL)-cholesterol(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Change in systolic blood pressure(Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits)
- Change in siastolic blood pressure(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Proportion of current smokers(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Muscle strength(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Vitamin E value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Change in muscle strength(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Proportion of pancreas specific mortality(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Changes in BMI(Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits)
- Serum total cholesterol(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Change in serum triglyceride(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Systolic blood pressure value(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Serum albumin value(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Change in vitamin A value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Vitamin D value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Change in vitamin K value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Change in quality of life(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Serum triglyceride(Data will be recorded during the 3-6-12-18-24 months followup visits)
- Change in serum high density liporpotein(HDL)-cholesterol(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Change in serum low density liporpotein(LDL)-cholesterol(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Change in serum albumin value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Vitamin A value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Vitamin K value(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
- Change in smoking(Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits)
研究者
Dr Hegyi Péter
Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs
University of Pecs