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临床试验/NCT07169786
NCT07169786尚未招募不适用

The Association Between Dietary Pattern and the Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus

Mariam Emeel Haleem Naseem0 个研究点目标入组 160 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
主要终点
Evaluation of the influence of dietary pattern on the progression of chronic kidney disease among patients with type 2 Diabetes Milletus

研究概览

简要总结

The aim of this study is to investigate the relationship between dietary patterns and the progression of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus.

详细描述

Chronic kidney disease (CKD) is a prevalent and serious complication among patients with type 2 diabetes mellitus (T2DM), affecting up to 40% of diabetic individuals and significantly contributing to morbidity and mortality . The interplay between T2DM and CKD is complex, with diabetic kidney disease (DKD) representing a leading cause of end-stage renal disease worldwide Diet is a modifiable risk factor with a profound impact on both the development and progression of CKD in patients with T2DM. Western dietary patterns, characterized by high intakes of salt, saturated fat, red and processed meats, and refined sugars, are associated with increased risk of hypertension, glomerular damage, and accelerated kidney dysfunction.

Conversely, diets rich in vegetables, fruits, whole grains, fiber, legumes, and plant-based proteins have been linked to protective effects against CKD progression. For instance, moderate vegetable protein intake appears to offer renal protection, while excessive consumption of red and processed meats burdens the kidneys and accelerates dysfunction Dietary recommendations should be individualized, taking into account disease severity, comorbidities, and patient preferences This study will investigate the relationship between dietary patterns and the progression of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus The aim of this study is to investigate the relationship between dietary patterns and the progression of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus. This study seeks to

  1. Assess how different types of diets (e.g., Mediterranean, DASH, plant-based, high-protein, low-protein) influence the rate of CKD progression in individuals with T2DM.
  2. Evaluate the impact of specific dietary components-such as protein and sodium intake-on renal function markers, including estimated glomerular filtration rate (eGFR) and albuminuria, in this patient population.
  3. Identify dietary factors that may be protective or detrimental to kidney health in patients with T2DM, with the goal of informing evidence-based dietary recommendations for slowing CKD progression Methodology 2.4.1- Type of the study cross-sectional, observational study

2.4. 2- Study Setting: The study will be conducted in the internal medicine department in Assiut University hospital.

2.4. 3- Study subjects:

  1. Inclusion criteria:

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Adults aged above 18 years
  • Diagnosed with type 2 diabetes mellitus according to ADA criteria.
  • Diagnosed with chronic kidney disease stages 1-4 (eGFR 15-90 mL/min/1.73 m²) for at least 3 months.
  • Willing and able to provide informed consent

排除标准

  • • Patients with end-stage renal disease (CKD stage 5 or on dialysis).
  • History of kidney transplantation.
  • Acute kidney injury within the past 3 months.
  • Pregnant or lactating women.
  • Patients with severe comorbid conditions (e.g., active malignancy, severe heart failure).
  • Use of medications known to significantly affect renal function (other than standard antihypertensive or antidiabetic therapy).

结局指标

主要结局

Evaluation of the influence of dietary pattern on the progression of chronic kidney disease among patients with type 2 Diabetes Milletus

时间窗: 6 month

Primary Outcomes Measures 1\. change in estimated glomerular filtration rate (eGFR) from baseline to 6 month using CKD-EPI formula mL/min/1.73 m² Time frame 6 month

次要结局

未报告次要终点

研究者

发起方
Mariam Emeel Haleem Naseem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mariam Emeel Haleem Naseem

resident physician ,internal medicine

Assiut University

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