Chronic Kidney DiseasePhase 2NCT00994838
Reduced Calorie Diet Intervention in Kidney Transplant Recipients
A Phase 2 study testing reduced calorie diet in people with Chronic Kidney Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to measure the effect of a reduced calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance. 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?
- reduced calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jan 2014
- 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
- Age 18 years to 65 years;
- BMI 25 to 40 kg/m2;
- First time kidney transplant;
- Single organ transplant;
- Ability to understand and voluntarily provide informed consent.
Who cannot join
- Type 1 DM;
- Type 2 DM on diabetic medications/insulin;
- Biopsy proven acute rejection in the first 3 months post transplant;
- Active coronary disease;
- Immunosuppressive therapy at time of transplant (use prior to what is given for transplant procedure);
- Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
- Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The purpose of this study is to measure the effect of a reduced calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.
Read the detailed description
Kidney transplantation is the preferred renal replacement therapy for end stage renal disease (ESRD) because it affords survival and quality of life advantages over maintenance dialysis.1 The number of transplants performed increases each year, with currently over 150,000 individuals living in the United States with a kidney transplant. This is in the setting of 68,000 patients on the wait list with a median wait time of 4 years for an available organ.2 Despite the survival benefit over dialysis, transplanted patients still have a greatly increased risk of cardiovascular disease (CVD) over the general population, and CVD is the leading cause of death among recipients with a functioning graft.3 Given the long wait times for kidneys due to organ shortage, extensive resources used, and support needed for each transplant procedure, it is imperative that we improve long term patient and graft survival. Accordingly, modification of CVD risk profile is of paramount importance in kidney transplant patients.
The etiology of increased risk of CVD in kidney transplant patients is multi-factorial and includes the high burden of CVD and its risk factors present prior to transplant, as well as increasing prevalence of these risk factors in the post transplant period due to transplant associated weight gain, immunosuppression side effects, metabolic consequences of a functioning kidney, and allograft dysfunction. Efforts to reduce CVD risk factors have yet to be adequately implemented and rigorously studied in the kidney transplant population.
Obesity at the time of transplant is common and associated with several CVD risk factors post transplant, including hypertension, hyperlipidemia, diabetes mellitus, metabolic syndrome, and inflammation. Obesity is also associated with potentially poorer graft outcomes, including death censored graft loss and chronic allograft failure.4 In addition, the majority of patients gain weight post transplantation, primarily in the form of fat mass. Post transplant weight gain is also associated with increased prevalence of known CVD risk factors, CVD death, and graft loss.5 The increased burden of CVD in kidney transplant patients makes obesity prevention and treatment strategies appealing interventions to improve long-term outcomes, both in terms of graft and overall survival. In this study we will measure the effect of a low calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.
- Conditions
- Chronic Kidney Disease
- Being tested
- reduced calorie 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.
reduced calorie dietOther
10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption
| Study group | Role | What they receive |
|---|---|---|
| reduced calorie diet | Active comparator | 10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption Receives: Other: reduced calorie diet |
| standard diet | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
a significant improvement in measures of body composition (including weight, BMI, and fat mass)
Measured: 12 months
Secondary outcomes (3)
an improvement in insulin resistance
Measured: 12 months
a decrease in oxidative stress markers
Measured: 12 months
an improvement in kidney function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2014
- Study completionJan 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.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Birdwell, Vanderbilt University
- Investigators
- Kelly A Birdwell, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994838
- Sponsor's protocol ID
- 091030
- Status last verified
- Jul 2015
- First submitted
- 12 Oct 2009
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Calorie Diet Intervention in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00994838
- Acronym / sponsor ID
- 091030
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Oct 2009 (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 this study is to measure the effect of a reduced calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.
Detailed description
Kidney transplantation is the preferred renal replacement therapy for end stage renal disease (ESRD) because it affords survival and quality of life advantages over maintenance dialysis.1 The number of transplants performed increases each year, with currently over 150,000 individuals living in the United States with a kidney transplant. This is in the setting of 68,000 patients on the wait list with a median wait time of 4 years for an available organ.2 Despite the survival benefit over dialysis, transplanted patients still have a greatly increased risk of cardiovascular disease (CVD) over the general population, and CVD is the leading cause of death among recipients with a functioning graft.3 Given the long wait times for kidneys due to organ shortage, extensive resources used, and support needed for each transplant procedure, it is imperative that we improve long term patient and graft survival. Accordingly, modification of CVD risk profile is of paramount importance in kidney transplant patients.
The etiology of increased risk of CVD in kidney transplant patients is multi-factorial and includes the high burden of CVD and its risk factors present prior to transplant, as well as increasing prevalence of these risk factors in the post transplant period due to transplant associated weight gain, immunosuppression side effects, metabolic consequences of a functioning kidney, and allograft dysfunction. Efforts to reduce CVD risk factors have yet to be adequately implemented and rigorously studied in the kidney transplant population.
Obesity at the time of transplant is common and associated with several CVD risk factors post transplant, including hypertension, hyperlipidemia, diabetes mellitus, metabolic syndrome, and inflammation. Obesity is also associated with potentially poorer graft outcomes, including death censored graft loss and chronic allograft failure.4 In addition, the majority of patients gain weight post transplantation, primarily in the form of fat mass. Post transplant weight gain is also associated with increased prevalence of known CVD risk factors, CVD death, and graft loss.5 The increased burden of CVD in kidney transplant patients makes obesity prevention and treatment strategies appealing interventions to improve long-term outcomes, both in terms of graft and overall survival. In this study we will measure the effect of a low calorie diet intervention in new kidney transplant recipients on the outcomes weight gain, oxidative stress, and insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reduced calorie diet | Active comparator | Other: reduced calorie diet10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption |
| standard diet | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years to 65 years;
- BMI 25 to 40 kg/m2;
- First time kidney transplant;
- Single organ transplant;
- Ability to understand and voluntarily provide informed consent.
Key exclusion criteria (7 listed)
- Type 1 DM;
- Type 2 DM on diabetic medications/insulin;
- Biopsy proven acute rejection in the first 3 months post transplant;
- Active coronary disease;
- Immunosuppressive therapy at time of transplant (use prior to what is given for transplant procedure);
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 |
|---|---|---|
| reduced calorie diet10% reduction in total daily calories (≈ 300 kcal reduction) from carbohydrates and fat from the usual daily energy consumption | Other | reduced calorie diet |
Primary outcome
a significant improvement in measures of body composition (including weight, BMI, and fat mass)
Time frame: 12 months
3 secondary outcomes
an improvement in insulin resistance
Time frame: 12 months
a decrease in oxidative stress markers
Time frame: 12 months
an improvement in kidney function
Time frame: 12 months
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 17 Jul 2015.
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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.
Kelly A Birdwell, 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 reduced calorie 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 7 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 17 Jul 2015. 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 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?
a significant improvement in measures of body composition (including weight, BMI, and fat mass) (time frame: 12 months). 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 17 Jul 2015.