Chronic Kidney DiseasePhase 2NCT00581269
Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
A Phase 2 study testing low-impact aerobic exercise and low-calorie (low-fat) diet in people with Chronic Kidney Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The oxidative stress and inflammatory state is known to contribute to the pathogenesis of atherosclerosis, and is predictive of cardiovascular events and mortality rates in the general population and patients with chronic kidney disease (CKD), particularly in patients with end stage renal disease (ESRD) on dialysis… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- low-impact aerobic exercise and low-calorie (low-fat) diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Apr 2009
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Stage III-IV (estimated GFR 20-59 min/ml) chronic kidney disease measured by MDRD formula.
- BMI ≥ 30 kg/m2
- Age > 18 or < 65 years.
- Life expectancy greater than one year.
- Ability to understand and provide informed consent for participation in the study.
Who cannot join
- Active inflammatory disease such as: AIDS (HIV seropositivity is not an exclusion criteria), active hepatitis C or B, active gout, other active inflammatory diseases.
- Active malignancy excluding basal or squamous cell carcinoma of the skin.
- Patients suffering from Type I Diabetes Mellitus
- Patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
- Patients who are already on a consistent and rigorous exercise regimen.
- Gastrointestinal dysfunction requiring parental nutrition.
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- History of functional kidney transplant < 6 months prior to study entry.
- Anticipated live donor kidney transplant over study duration.
- Patients taking anti-inflammatory medication except aspirin < 325mg/day over the past 30 days.
- Patients taking Vitamin E supplements > 60 IU/day, vitamin C > 500mg/day over the past 30days.
- Patients taking any prednisone therapy.
- Hospital admission within the last 30 days.
- On experimental drug protocols.
- Significant cardiac or vascular disease (symptomatic disease; CV event(s) within the last year; significant occlusive atherosclerotic disease or ischemic disease on non-invasive or invasive diagnostic procedures).
- Significant physical disability or immobility (joint disease, joint replacement, muscular disorders).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The oxidative stress and inflammatory state is known to contribute to the pathogenesis of atherosclerosis, and is predictive of cardiovascular events and mortality rates in the general population and patients with chronic kidney disease (CKD), particularly in patients with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and inflammation has been identified in all stages of CKD, ranging from moderate renal insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and inflammation associated with the development of CKD is currently poorly understood.
There is also concern about the epidemic of obesity in the United States, as the overall health status of the general population is adversely affected by increasing adiposity. Recent studies indicate a strong relationship between adiposity and incident CKD. Furthermore, the presence of an elevated body mass index (BMI) is an independent predictor for progression to ESRD, even after additional adjustments for baseline blood pressure and the presence or absence of diabetes mellitus. Limited data in the general population show that healthy lifestyle interventions, such as exercise and dietary caloric restriction, either alone or in combination, reduce the inflammatory and oxidative stress burden seen in obese subjects. The impact of healthy lifestyle modifications on inflammation and oxidative stress has not been investigated in the obese CKD population. Based on the foregoing observations, the purpose of this investigation will be to determine whether healthy lifestyle interventions in the form of low-impact aerobic exercise and dietary calorie restriction in obese subjects (BMI ≥ 30kg/m2) with moderate to severe (Stage III-IV) CKD [estimated glomerular filtration rate (GFR) 20-59 ml/min] will improve oxidative stress, inflammation, insulin resistance, adipocytokines, endothelial dysfunction, and quality of life.
- Conditions
- Chronic Kidney Disease
- Being tested
- low-impact aerobic exercise, low-calorie (low-fat) diet
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-impact aerobic exerciseBehavioural
subjects will undergo supervised physical activity for a maximum of 30-60 minutes, every other day, 3 days per week for 3 months; to offer variety in the exercise prescription, subjects will alternately use a treadmill, an elliptical trainer, a Nu-Step cross-trainer and a recumbent stationary bicycle
low-calorie (low-fat) dietDietary supplement
subjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | low-impact aerobic exercise group Receives: Behavioral: low-impact aerobic exercise |
| 2 | Active comparator | dietary restriction group Receives: Dietary Supplement: low-calorie (low-fat) diet |
| 3 | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker
Measured: 3 months
a statistically significant decrease in hs-CRP, a specific inflammatory marker
Measured: 3 months
Secondary outcomes (4)
significant changes in additional markers of oxidative stress and inflammation
Measured: 3 months
significant changes in insulin resistance and adipocytokines
Measured: 3 months
a significant improvement in endothelial function as measured by brachial artery FMD
Measured: 3 months
a significant improvement in quality of life scores
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: the Fellow conducting the study left the institution in 2009
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Investigators
- Alp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581269
- Sponsor's protocol ID
- 070990
- Status last verified
- Nov 2010
- First submitted
- 18 Dec 2007
- Last updated
- 3 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00581269
- Acronym / sponsor ID
- 070990
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the Fellow conducting the study left the institution in 2009
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Dec 2007 (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 oxidative stress and inflammatory state is known to contribute to the pathogenesis of atherosclerosis, and is predictive of cardiovascular events and mortality rates in the general population and patients with chronic kidney disease (CKD), particularly in patients with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and inflammation has been identified in all stages of CKD, ranging from moderate renal insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and inflammation associated with the development of CKD is currently poorly understood.
There is also concern about the epidemic of obesity in the United States, as the overall health status of the general population is adversely affected by increasing adiposity. Recent studies indicate a strong relationship between adiposity and incident CKD. Furthermore, the presence of an elevated body mass index (BMI) is an independent predictor for progression to ESRD, even after additional adjustments for baseline blood pressure and the presence or absence of diabetes mellitus. Limited data in the general population show that healthy lifestyle interventions, such as exercise and dietary caloric restriction, either alone or in combination, reduce the inflammatory and oxidative stress burden seen in obese subjects. The impact of healthy lifestyle modifications on inflammation and oxidative stress has not been investigated in the obese CKD population. Based on the foregoing observations, the purpose of this investigation will be to determine whether healthy lifestyle interventions in the form of low-impact aerobic exercise and dietary calorie restriction in obese subjects (BMI ≥ 30kg/m2) with moderate to severe (Stage III-IV) CKD [estimated glomerular filtration rate (GFR) 20-59 ml/min] will improve oxidative stress, inflammation, insulin resistance, adipocytokines, endothelial dysfunction, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: low-impact aerobic exerciselow-impact aerobic exercise group |
| 2 | Active comparator | Dietary Supplement: low-calorie (low-fat) dietdietary restriction group |
| 3 | No intervention | –control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with Stage III-IV (estimated GFR 20-59 min/ml) chronic kidney disease measured by MDRD formula.
- BMI ≥ 30 kg/m2
- Age > 18 or < 65 years.
- Life expectancy greater than one year.
- Ability to understand and provide informed consent for participation in the study.
Key exclusion criteria (15 listed)
- Active inflammatory disease such as: AIDS (HIV seropositivity is not an exclusion criteria), active hepatitis C or B, active gout, other active inflammatory diseases.
- Active malignancy excluding basal or squamous cell carcinoma of the skin.
- Patients suffering from Type I Diabetes Mellitus
- Patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
- Patients who are already on a consistent and rigorous exercise regimen.
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 |
|---|---|---|
| low-impact aerobic exercisesubjects will undergo supervised physical activity for a maximum of 30-60 minutes, every other day, 3 days per week for 3 months; to offer variety in the exercise prescription, subjects will alternately use a treadmill, an elliptical trainer, a Nu-Step cross-trainer and a recumbent stationary bicycle | Behavioural | 1 |
| low-calorie (low-fat) dietsubjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months | Dietary supplement | 2 |
Primary outcome
a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker
Time frame: 3 months
a statistically significant decrease in hs-CRP, a specific inflammatory marker
Time frame: 3 months
4 secondary outcomes
significant changes in additional markers of oxidative stress and inflammation
Time frame: 3 months
significant changes in insulin resistance and adipocytokines
Time frame: 3 months
a significant improvement in endothelial function as measured by brachial artery FMD
Time frame: 3 months
a significant improvement in quality of life scores
Time frame: 3 months
Results and safety
The study was stopped early (reason given: the Fellow conducting the study left the institution in 2009). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2010.
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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.
Alp Ikizler, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low-impact aerobic exercise and low-calorie (low-fat) diet in people with Chronic Kidney Disease, run by Vanderbilt University 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 Nov 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the Fellow conducting the study left the institution in 2009). Results are not available in the source record.
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?
a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker (time frame: 3 months). The study lists 2 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 3 Nov 2010.