NCT01769963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

January 15, 2013

Last Update Submit

March 28, 2014

Conditions

Chronic Kidney Disease

Keywords

Advanced glycation end-productschronic kidney diseasenutritioninflammationinsulin resistanceendothelial function

Outcome Measures

Primary Outcomes (4)

  • N-epsilon-carboxymethyllysine (CML)

    Change in CML concentrations

    baseline, one week and three weeks

  • Inflammatory biomarkers

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

    baseline, one week and three weeks

  • Indices of insulin sensitivity

    Change in HOMA-IR

    baseline, one week and three weeks

  • Flow-mediated dilation (FMD)

    Changes in brachial FMD

    one week and three weeks

Study Arms (1)

Dietary intervention

EXPERIMENTAL

All participants will be fed a high AGE diet followed by a low AGE diet (single arm study)

Other: Research diet

Interventions

Research dietOTHER

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).

Dietary intervention

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate CKD (estimated glomerular filtration rate 15 - 59 ml/min/1.73m2).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicInflammationInsulin Resistance

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Orlando M Gutiérrez, MD, MMSc

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

April 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

US(1)