Insulin ResistancePhase 3NCT01496092
Study of Keto Acid (KA) on Insulin Resistance in Peritoneal Dialysis (PD) Patients
A Phase 3 study testing Keto Acid in people with Insulin Resistance, run by Peking University First Hospital at 1 site in China.
Trial summary
The overarching aim of this proposal is to examine the effects of usual protein diet supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis (PD). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Keto Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically stable and receiving stable PD >= 3 months
- age 18-80 years
- body mass index > 18.5
- Kt/v >= 1.7 or Tccr >= 50l/week/1.73m2
- glucose lactate-buffered PD solutions
Who cannot join
- pregnancy
- intolerance to the study protocols
- severe, unstable, active, or chronic inflammation disease
- chronic use of anti-inflammatory medication
- severe malnutrition
- a high probability of receiving a kidney transplant or transferring to HD within 6 months
- taking anti-inflammatory medication chronically or taking KA during the past one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Regular Protein Diet Supplemented With Keto Acid on Insulin Resistance In Peritoneal Dialysis Patients
The overarching aim of this proposal is to examine the effects of usual protein diet supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis (PD). The investigators will achieve this goal through a randomized controlled trial of administration of usual protein diet plus KA versus usual protein diet alone in patients on peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study will provide potential avenues for improvement of metabolic profile of patients on PD and possibly improve long-term outcomes such as cardiovascular disease risk and death.
Read the detailed description
Specific Aims and Significance:
To evaluate the effects of KA plus usual protein diet on basal and stimulated insulin sensitivity in PD patients.
Hypothesis: Administration of KA plus usual protein diet will improve insulin resistance in peritoneal dialysis patients.
To evaluate the influence of KA plus usual protein diet on non-traditional cardiovascular disease (CVD) markers (markers of inflammation and oxidative stress) in PD patients.
Hypothesis: Administration of KA plus usual protein diet will improve markers of inflammation and oxidative stress in PD patients.
Background and Rationale:
Insulin Resistance in Peritoneal Dialysis Patients. Insulin resistance (IR), the reciprocal of insulin sensitivity, describes a state of reduced biological effect for any given concentration of insulin in the plasma. Insulin resistance plays a major pathophysiological role in glucose intolerance and Type 2 diabetes mellitus (T2DM) and is tightly associated with major public health problems including obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Insulin resistance, measured by homeostatic model assessment (HOMA-IR), is reported to be common in chronic kidney disease (CKD) patients, including ones on PD and hemodialysis (HD). HOMA-IR is also shown to be an independent predictor of cardiovascular mortality in non-diabetic maintenance HD patients although the pathophysiological link has not been clearly delineated.
A unique aspect of PD that predisposes patients to IR is the inevitable glucose load from the dialysate required for ultrafiltration. Consequently, the prevalence of metabolic syndrome such as hyperglycemia, dyslipidemia and weight gain is increased in PD patients. As an individual component of metabolic syndrome, IR is significantly higher in PD patients than in HD or pre-dialysis patients (47% vs 21% or 26%). Accordingly, improvement of IR could be a potential intervention to decrease the CVD risk and mortality in PD patients. However, only a few investigations have centered on interventions to ameliorate IR in these patients.
Low Protein Diet Supplemented with Keto Acid as a Potential Strategy to Ameliorate Insulin Resistance in PD Patients. Several small scale studies exploring the effects of low protein diet (LPD) plus KA on glucose metabolism indicated that LPD-KA could improve liver and peripheral tissue insulin sensitivity in CKD patients not yet on maintenance dialysis. There are no studies exploring such effects in maintenance dialysis patients, especially in PD patients. One potential mechanism for the improvement in insulin resistance by KA is the reduction of circulating uremic toxins, although the specific elements are not well delineated. In addition, the supplementation of KA might be helpful since plasma total branched-chain amino acid concentrations correlate with glucose tolerance index in dialysis patients. Since the safety of LPD has not been entirely shown in previous studies for PD patients, and our data indicated that DPI < 0.74g/kg/d was harmful in the long-term PD, the investigators will not provide the LPD for improving the IR. However, the exploration of possible benefits of KA plus usual protein intake in PD patients on insulin sensitivity is intriguing.
- Conditions
- Insulin Resistance
- Being tested
- Keto Acid
- Keywords
- Keto Acid, Peritoneal dialysis, Insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keto AcidDrug
Also called Compound α-Ketoacid Tablets
12 tablets per day
| Study group | Role | What they receive |
|---|---|---|
| Keto Acid supplemented with usual protein diet | Experimental | Not described Receives: Drug: Keto Acid |
| usual protein diet | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Insulin sensitivity will be measured using HOMA-IR.
Measured: at 0, 12, 24 week after patients start their study prescription
Secondary outcomes (3)
Oxidative stress
Oxidative stress will be assessed by Plasma OxLDL.
Measured: at 0, 12, 24 week after patients start their study prescription
Inflammatory state
Inflammatory state will be assessed by C-reactive protein, pro-inflammatory cytokine levels (IL-6) and adipokines (leptin and adiponectin).
Measured: at 0, 12, 24 week after patients start their study prescription
Endothelial dysfunction
sICAM and sVCAM will be measured.
Measured: at 0, 12, 24 week after patients start their study prescription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, MD,PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496092
- Sponsor's protocol ID
- KAPD
- Status last verified
- Feb 2014
- First submitted
- 19 Aug 2011
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Protein Diet Supplemented With Keto Acid on Insulin Resistance In Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT01496092
- Acronym / sponsor ID
- KAPD
- Conditions
- Insulin Resistance
- Keywords
- Keto Acid, Peritoneal dialysis, Insulin resistance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Vanderbilt University
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Dec 2011 (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 overarching aim of this proposal is to examine the effects of usual protein diet supplemented with keto acid (KA) on insulin sensitivity in patients on peritoneal dialysis (PD). The investigators will achieve this goal through a randomized controlled trial of administration of usual protein diet plus KA versus usual protein diet alone in patients on peritoneal dialysis (PD) over a period of 6 months. If successful, the results of this study will provide potential avenues for improvement of metabolic profile of patients on PD and possibly improve long-term outcomes such as cardiovascular disease risk and death.
Detailed description
Specific Aims and Significance:
To evaluate the effects of KA plus usual protein diet on basal and stimulated insulin sensitivity in PD patients.
Hypothesis: Administration of KA plus usual protein diet will improve insulin resistance in peritoneal dialysis patients.
To evaluate the influence of KA plus usual protein diet on non-traditional cardiovascular disease (CVD) markers (markers of inflammation and oxidative stress) in PD patients.
Hypothesis: Administration of KA plus usual protein diet will improve markers of inflammation and oxidative stress in PD patients.
Background and Rationale:
Insulin Resistance in Peritoneal Dialysis Patients. Insulin resistance (IR), the reciprocal of insulin sensitivity, describes a state of reduced biological effect for any given concentration of insulin in the plasma. Insulin resistance plays a major pathophysiological role in glucose intolerance and Type 2 diabetes mellitus (T2DM) and is tightly associated with major public health problems including obesity, hypertension, dyslipidemia, and atherosclerotic cardiovascular disease. Insulin resistance, measured by homeostatic model assessment (HOMA-IR), is reported to be common in chronic kidney disease (CKD) patients, including ones on PD and hemodialysis (HD). HOMA-IR is also shown to be an independent predictor of cardiovascular mortality in non-diabetic maintenance HD patients although the pathophysiological link has not been clearly delineated.
A unique aspect of PD that predisposes patients to IR is the inevitable glucose load from the dialysate required for ultrafiltration. Consequently, the prevalence of metabolic syndrome such as hyperglycemia, dyslipidemia and weight gain is increased in PD patients. As an individual component of metabolic syndrome, IR is significantly higher in PD patients than in HD or pre-dialysis patients (47% vs 21% or 26%). Accordingly, improvement of IR could be a potential intervention to decrease the CVD risk and mortality in PD patients. However, only a few investigations have centered on interventions to ameliorate IR in these patients.
Low Protein Diet Supplemented with Keto Acid as a Potential Strategy to Ameliorate Insulin Resistance in PD Patients. Several small scale studies exploring the effects of low protein diet (LPD) plus KA on glucose metabolism indicated that LPD-KA could improve liver and peripheral tissue insulin sensitivity in CKD patients not yet on maintenance dialysis. There are no studies exploring such effects in maintenance dialysis patients, especially in PD patients. One potential mechanism for the improvement in insulin resistance by KA is the reduction of circulating uremic toxins, although the specific elements are not well delineated. In addition, the supplementation of KA might be helpful since plasma total branched-chain amino acid concentrations correlate with glucose tolerance index in dialysis patients. Since the safety of LPD has not been entirely shown in previous studies for PD patients, and our data indicated that DPI < 0.74g/kg/d was harmful in the long-term PD, the investigators will not provide the LPD for improving the IR. However, the exploration of possible benefits of KA plus usual protein intake in PD patients on insulin sensitivity is intriguing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keto Acid supplemented with usual protein diet | Experimental | Drug: Keto Acid |
| usual protein diet | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- medically stable and receiving stable PD >= 3 months
- age 18-80 years
- body mass index > 18.5
- Kt/v >= 1.7 or Tccr >= 50l/week/1.73m2
- glucose lactate-buffered PD solutions
Key exclusion criteria (7 listed)
- pregnancy
- intolerance to the study protocols
- severe, unstable, active, or chronic inflammation disease
- chronic use of anti-inflammatory medication
- severe malnutrition
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 |
|---|---|---|
| Keto AcidAlso: Compound α-Ketoacid Tablets12 tablets per day | Drug | Keto Acid supplemented with usual protein diet |
Primary outcome
Insulin resistance
Time frame: at 0, 12, 24 week after patients start their study prescription
Insulin sensitivity will be measured using HOMA-IR.
3 secondary outcomes
Oxidative stress
Time frame: at 0, 12, 24 week after patients start their study prescription
Inflammatory state
Time frame: at 0, 12, 24 week after patients start their study prescription
Endothelial dysfunction
Time frame: at 0, 12, 24 week after patients start their study prescription
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 21 Feb 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.
Jie Dong, MD,PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Keto Acid in people with Insulin Resistance, run by Peking University First Hospital at 1 site in China.
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 21 Feb 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Insulin resistance (time frame: at 0, 12, 24 week after patients start their study prescription). 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 21 Feb 2014.