Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease|
- N-epsilon-carboxymethyllysine (CML) [ Time Frame: baseline, one week and three weeks ] [ Designated as safety issue: No ]Change in CML concentrations
- Inflammatory biomarkers [ Time Frame: baseline, one week and three weeks ] [ Designated as safety issue: No ]Change in interleukins 1, 6 and 10, c-reactive protein
- Indices of insulin sensitivity [ Time Frame: baseline, one week and three weeks ] [ Designated as safety issue: No ]Change in HOMA-IR
- Flow-mediated dilation (FMD) [ Time Frame: one week and three weeks ] [ Designated as safety issue: No ]Changes in brachial FMD
|Study Start Date:||April 2012|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Dietary intervention
All participants will be fed a high AGE diet followed by a low AGE diet (single arm study)
Other: Research diet
Participants will be provided specially prepared meals to eat at home for three weeks. During the first week, participants will eat foods that have standard amounts of AGEs in them (this is called the control diet). During the second and third weeks, participants will eat the same foods, only they will be prepared in our kitchen in a way that limits the amount of AGEs in them (called the intervention diet).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769963
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Orlando M Gutiérrez, MD, MMSc||University of Alabama at Birmingham|