End Stage Renal DiseaseNCT01119196
The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
A study testing Icodextrin dialysate in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The goal of this study is to examine the relevance of insulin resistance in peritoneal dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do so through a prospective randomized study using Icodextrin as an alternate dialysate solution to routine glucose-based dialysate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Icodextrin dialysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jan 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medically stable and receiving stable PD for ≥ 3 months;
- BMI ≤ 45;
- Most recent Kt/V ≥1.7 or Tccr ≥ 50l/week/1.73m2;
- On Glucose lactate-buffered PD solutions with consistent glucose exposure.
Who cannot join
- Pregnancy or breast-feeding;
- Intolerance to the study protocols;
- Severe, unstable, active, or chronic inflammation disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
- Chronic use of anti-inflammatory medication except low dose (< 10mg/d) prednisone;
- Severe hypokalemia (K+ level < 3.0 mEq/L);
- Hypercalcemia (Ca++ level > 11.0 mg/dL);
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- Have a glycogen storage disease;
- Intolerant to maltose or isomaltose;
- Allergic to cornstarch or icodextrin;
- Recent abdominal surgery in the past 30 days;
- Chronic Obstructive Lung Disease (COPD) or Interstitial lung disease;
- Insulin-Dependent Diabetes Mellitus (IDDM).
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The goal of this study is to examine the relevance of insulin resistance in peritoneal dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do so through a prospective randomized study using Icodextrin as an alternate dialysate solution to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement of conventional dialysate with glucose-sparing dialysate preparations will improve insulin resistance and associated metabolic disturbances in PD patients.
- Conditions
- End Stage Renal Disease
- Being tested
- Icodextrin dialysate
- Keywords
- Peritoneal Dialysis, Insulin resistance
- Medical subject headings
- Kidney Failure, Chronic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icodextrin dialysateOther
use of alternate SOC dialysate
| Study group | Role | What they receive |
|---|---|---|
| glucose-based dialysate | No intervention | most frequently used Standard of Care (SOC) dialysate |
| Icodextrin dialysate | Other | alternate SOC dialysate Receives: Other: Icodextrin dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in glucose disposal rate
Measured: 12 weeks
Secondary outcomes (1)
the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ikizler, Vanderbilt University
- Investigators
- Alp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119196
- Sponsor's protocol ID
- 100177
- Status last verified
- Sep 2016
- First submitted
- 5 May 2010
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Insulin Resistance in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01119196
- Acronym / sponsor ID
- 100177
- Conditions
- End Stage Renal Disease
- Keywords
- Peritoneal Dialysis, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 May 2010 (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 goal of this study is to examine the relevance of insulin resistance in peritoneal dialysis (PD) patients as well as the means to improve this metabolic derangement. We will do so through a prospective randomized study using Icodextrin as an alternate dialysate solution to routine glucose-based dialysate. We hypothesize that (1) the glucose loading associated with PD leads to impairment in insulin sensitivity, (2) the degree of insulin resistance is dependent on the basal metabolic state (fasting versus stimulated), and (3) the replacement of conventional dialysate with glucose-sparing dialysate preparations will improve insulin resistance and associated metabolic disturbances in PD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucose-based dialysate | No intervention | –most frequently used Standard of Care (SOC) dialysate |
| Icodextrin dialysate | Other | Other: Icodextrin dialysatealternate SOC dialysate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Medically stable and receiving stable PD for ≥ 3 months;
- BMI ≤ 45;
- Most recent Kt/V ≥1.7 or Tccr ≥ 50l/week/1.73m2;
- On Glucose lactate-buffered PD solutions with consistent glucose exposure.
Key exclusion criteria (12 listed)
- Pregnancy or breast-feeding;
- Intolerance to the study protocols;
- Severe, unstable, active, or chronic inflammation disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
- Chronic use of anti-inflammatory medication except low dose (< 10mg/d) prednisone;
- Severe hypokalemia (K+ level < 3.0 mEq/L);
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 |
|---|---|---|
| Icodextrin dialysateuse of alternate SOC dialysate | Other | Icodextrin dialysate |
Primary outcome
improvement in glucose disposal rate
Time frame: 12 weeks
1 secondary outcome
the Pearson or Spearman correlation coefficient values between insulin resistance (IR) measured by insulin clamp study and other methods (e.g., HOMA, QUICKI, OGTT)
Time frame: 12 weeks
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 26 Sep 2016.
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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 study testing Icodextrin dialysate in people with End Stage Renal 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 4 inclusion and 12 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 26 Sep 2016. 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?
improvement in glucose disposal rate (time frame: 12 weeks). 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 26 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.