Chronic Kidney DiseaseNCT01769963
Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease
A study testing Research diet in people with Chronic Kidney Disease, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Research diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate CKD (estimated glomerular filtration rate 15 - 59 ml/min/1.73m2).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Research diet
- Keywords
- Advanced glycation end-products, chronic kidney disease, nutrition, inflammation, insulin resistance, endothelial function
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | All participants will be fed a high AGE diet followed by a low AGE diet (single arm study) Receives: Other: Research diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-epsilon-carboxymethyllysine (CML)
Change in CML concentrations
Measured: baseline, one week and three weeks
Inflammatory biomarkers
Change in interleukins 1, 6 and 10, c-reactive protein
Measured: baseline, one week and three weeks
Indices of insulin sensitivity
Change in HOMA-IR
Measured: baseline, one week and three weeks
Flow-mediated dilation (FMD)
Changes in brachial FMD
Measured: one week and three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orlando M. Gutierrez, MD, MMSc, University of Alabama at Birmingham
- Investigators
- Orlando M Gutiérrez, MD, MMSc, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769963
- Sponsor's protocol ID
- F111220003
- Status last verified
- Mar 2014
- First submitted
- 15 Jan 2013
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Glycation End-products, Inflammation and Vascular Health in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01769963
- Acronym / sponsor ID
- F111220003
- Conditions
- Chronic Kidney Disease
- Keywords
- Advanced glycation end-products, chronic kidney disease, nutrition, inflammation, insulin resistance, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Other: Research dietAll participants will be fed a high AGE diet followed by a low AGE diet (single arm study) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mild to moderate CKD (estimated glomerular filtration rate 15 - 59 ml/min/1.73m2).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research dietParticipants 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). | Other | Dietary intervention |
Primary outcome
N-epsilon-carboxymethyllysine (CML)
Time frame: baseline, one week and three weeks
Change in CML concentrations
Inflammatory biomarkers
Time frame: baseline, one week and three weeks
Change in interleukins 1, 6 and 10, c-reactive protein
Indices of insulin sensitivity
Time frame: baseline, one week and three weeks
Change in HOMA-IR
Flow-mediated dilation (FMD)
Time frame: one week and three weeks
Changes in brachial FMD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orlando M Gutiérrez, MD, MMSc principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research diet in people with Chronic Kidney Disease, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-epsilon-carboxymethyllysine (CML) (time frame: baseline, one week and three weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.