Clinical trial NCT01769963: Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease
Official title: Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Advanced glycation end-products
chronic kidney disease
nutrition
inflammation
insulin resistance
endothelial function
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate CKD (estimated glomerular filtration rate 15 - 59 ml/min/1.73m2).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: N-epsilon-carboxymethyllysine (CML)
timeFrame: baseline, one week and three weeks
measure: Inflammatory biomarkers
timeFrame: baseline, one week and three weeks
measure: Indices of insulin sensitivity
timeFrame: baseline, one week and three weeks
measure: Flow-mediated dilation (FMD)
timeFrame: one week and three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Orlando M Gutiérrez, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: