Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- N-epsilon-carboxymethyllysine (CML)
研究概览
简要总结
The purpose of the study is to learn more about how advanced glycation end-products can affect insulin resistance, inflammation and blood vessel health in people with kidney disease.
详细描述
Advanced glycation end-products (AGEs) are compounds that form when sugars abnormally attach to proteins or lipids. High levels of AGEs in the blood may cause inflammation, problems with controlling blood sugar, and problems with the health of blood vessels. Many of the foods we commonly eat have high amounts of AGEs, which may increase AGEs in the blood of people with kidney disease. The amount of AGEs in foods can be lowered when prepared using special cooking techniques such as using moist heat or longer cooking times at lower temperatures. New research has shown that preparing food in this way can lower inflammation and improve blood vessel health in people with normal kidney function.
In this study, the investigators would like to examine the effect of lowering the AGE content of foods on inflammation, blood sugar control, and blood vessel health in individuals with mild to moderate chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate CKD (estimated glomerular filtration rate 15 - 59 ml/min/1.73m2).
排除标准
- •Current or past use of anti-glycemic medications
- •Fasting glucose > 126 mg/dl on screening visit or positive glucose on urine dipstick
- •Nephrotic-range proteinuria (≥ 3.5 grams per day as assessed by a spot urine albumin to creatinine ratio obtained at the screening visit)
- •Pregnancy or breast-feeding
- •Clinical need for a specialized diet (low sodium, low potassium, etc.) or religious dietary restrictions.
- •New or recent change (< 3 months) in dosage of medications known to affect vascular reactivity- angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers, calcium channel blockers, HMG-CoA reductase inhibitors, etc.
- •Current smoking or recent (< 6 months) cessation of smoking.
- •Poorly controlled hypertension (≥ 140 mm Hg systolic or 90 mm Hg diastolic), or prior history of malignant hypertensive episode (SBP > 200) off of blood pressure medications.
- •Participants with rapidly advancing renal failure.
- •Severe anemia, defined as a hemoglobin < 8 g/dL for men and < 6 g/dL for women.
结局指标
主要结局
N-epsilon-carboxymethyllysine (CML)
时间窗: baseline, one week and three weeks
Change in CML concentrations
Inflammatory biomarkers
时间窗: baseline, one week and three weeks
Change in interleukins 1, 6 and 10, c-reactive protein
Indices of insulin sensitivity
时间窗: baseline, one week and three weeks
Change in HOMA-IR
Flow-mediated dilation (FMD)
时间窗: one week and three weeks
Changes in brachial FMD
次要结局
未报告次要终点
研究者
Orlando M. Gutierrez, MD, MMSc
Principal Investigator
University of Alabama at Birmingham