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Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease

This study is currently recruiting participants.
Verified January 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01769963
First received: January 15, 2013
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
 Other: Research diet

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 15
Study Start Date: April 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769963

Contacts
Contact: Alexandra Luzuriaga-McPherson 205-975-9743 alexlm@uab.edu

Locations
United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Orlando M Gutiérrez, MD, MMSc University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01769963     History of Changes
Other Study ID Numbers: F111220003
Study First Received: January 15, 2013
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Advanced glycation end-products
chronic kidney disease
nutrition
 inflammation
insulin resistance
endothelial function

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Pathologic Processes
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 21, 2013