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OpenTrials
Completed

NCT Number: NCT01769963

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Research diet

Other

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).

Primary outcomes

  1. N-epsilon-carboxymethyllysine (CML)

    Time frame: baseline, one week and three weeks

    Change in CML concentrations

  2. Inflammatory biomarkers

    Time frame: baseline, one week and three weeks

    Change in interleukins 1, 6 and 10, c-reactive protein

  3. Indices of insulin sensitivity

    Time frame: baseline, one week and three weeks

    Change in HOMA-IR

  4. Flow-mediated dilation (FMD)

    Time frame: one week and three weeks

    Changes in brachial FMD

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 17, 2013
Registry last updated
Apr 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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