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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769963
• Other study ID #: F111220003
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: March 28, 2014
• Start date: April 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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).

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N-epsilon-carboxymethyllysine (CML)	Change in CML concentrations	baseline, one week and three weeks	No
Primary	Inflammatory biomarkers	Change in interleukins 1, 6 and 10, c-reactive protein	baseline, one week and three weeks	No
Primary	Indices of insulin sensitivity	Change in HOMA-IR	baseline, one week and three weeks	No
Primary	Flow-mediated dilation (FMD)	Changes in brachial FMD	one week and three weeks	No