NCT02294526已完成不适用
PILCHARDUS STUDY: A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders0 个研究点目标入组 35 人开始时间: 2012年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Change from baseline in fasting glucose at 6 months
研究概览
简要总结
Work hypothesis
A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40 years and < 85
- •BMI ≥ 25 and < 35
- •Patients diagnosed with type 2 diabetes at onset or treated only by diet
- •HbA1c between 6.0 and 8.0% (based on the last measured and documented laboratory measurement of the previous 3 months)
- •Usual consumption ≤ 3 fish per week
排除标准
- •T2D treated with antidiabetic oral drugs and/or insulin
- •Current or previous (within 3 months) intake of omega 3 suplements
- •Known allergy or intolerance to fish or fish protein
- •Diagnosis of active neoplasic disease
- •Suffering from an acute illness which requires a recovery period higher than one week
- •Currently chronic treatment with oral steroids or nonesteroidal anti-inflammatory for more than 5 days, at least 1 month before randomization
- •Pregnant or breast-feeding patients
- •Serious acute vascular events (cardiac or cerebral) diagnosed previous 2 months before the randomization
- •Current or previous (within 6 months) participation in another study
- •Chronic renal insufficiency (creatinine >1,5 mg/dl)
- •Any conditions that the investigator considers may render the patient unable to complete the study
- •During the interventional study, based on current standards of T2D care, doctors will introduce anti-diabetic oral drugs or insulin into the patient's treatment, where they consider it to be necessary.
研究组 & 干预措施
Sardine diet
Experimental
Subjects follow general dietary recommendations for diabetes including a fixed amount of sardine in daily meals (100g per day, 5 days a week) as part of their usual diet.
干预措施: Sardine diet (Other)
Control diet
No Intervention
Subjects only follow general dietary recommendations for diabetes.
结局指标
主要结局
Change from baseline in fasting glucose at 6 months
时间窗: Baseline and 6 months
Change from baseline in glycated hemoglobin (HbA1c) at 6 months
时间窗: Baseline and 6 months
Change from baseline in fasting insulin at 6 months
时间窗: Baseline and 6 months
次要结局
- Change from baseline in tumor necrosis factor alpha (TNFα) at 6 months(Baseline and 6 months)
- Change from baseline in specific bacterial groups of gut microbiota at 6 months(Baseline and 6 months)
- Change from baseline in HDL cholesterol at 6 months(Baseline and 6 months)
- Change from baseline in blood pressure at 6 months(Baseline and 6 months)
- Change from baseline in leptin at 6 months(Baseline and 6 months)
- Change from baseline in LDL cholesterol at 6 months(Baseline and 6 months)
- Change from baseline in adiponectin at 6 months(Baseline and 6 months)
- Change from baseline in ultra sensitive C-reactive protein (us-CRP) at 6 months(Baseline and 6 months)
- Change from baseline in interleukin-6 (IL-6) at 6 months(Baseline and 6 months)
- Change from baseline in interleukin-8 (IL-8) at 6 months(Baseline and 6 months)
- Change from baseline in interleukin-10 (IL-10) at 6 months(Baseline and 6 months)
- Change from baseline in erytrocite membrane fatty acid composition (EMFA) at 6 months(Baseline and 6 months)
- Change from baseline in total cholesterol at 6 months(Baseline and 6 months)
- Change from baseline in triglycerides at 6 months(Baseline and 6 months)
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