IMpact of n-3 Polyunsaturated Fatty Acids With a Protein-Enriched DiEt With Low Glycemic Index on Metabolic and Inflammatory Parameters in Type 2 Diabetic and Obese Patients: an Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- body weight change from baseline (non-diabetic patients)
研究概览
简要总结
Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched diet with low glycemic index to overweight and obese patients with insulin resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and all other patients, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight or obesity AND
- •insulin resistant OR pre-diabetes OR type 2 diabetes
排除标准
- •changes in anti-diabetic medication in the lat two months
- •acute illness during the last two weeks
- •HIV infection
- •hepatitis of other clinically significant hepatic disease other than non-alcoholic hepatic steatosis
- •severe or insufficiently treated cardiovascular, renal (GFR-MDRD < 60 ml/min) or pulmonary disease
- •Macroproteinuria (> 300 mg/g creatinine)
- •clinically significant or insufficiently treated thyroid disease
- •active malignant disease
- •inborn or acquired coagulopathy
结局指标
主要结局
body weight change from baseline (non-diabetic patients)
时间窗: 3 months
HbA1c change from baseline (type 2 diabetes patients)
时间窗: 3 months
次要结局
- change from baseline of inflammatory and metabolic parameters(3 months)
研究者
Thomas M Stulnig
Associate Professor
Medical University of Vienna