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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01769963
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Other: Research 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease
Study Start Date : April 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769963


Locations
United States, Alabama
University of Alabama
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

Responsible Party: Orlando M. Gutierrez, MD, MMSc, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01769963     History of Changes
Other Study ID Numbers: F111220003
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Orlando M. Gutierrez, MD, MMSc, 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
Pathologic Processes
Urologic Diseases
Renal Insufficiency