- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01496092
Study of Keto Acid (KA) on Insulin Resistance in Peritoneal Dialysis (PD) Patients
Effects of Regular Protein Diet Supplemented With Keto Acid on Insulin Resistance In Peritoneal Dialysis Patients
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Jie Dong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Keto Acid supplemented with usual protein diet
|
12 tablets per day
Other Names:
|
No Intervention: usual protein diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin resistance
Time Frame: at 0, 12, 24 week after patients start their study prescription
|
Insulin sensitivity will be measured using HOMA-IR.
|
at 0, 12, 24 week after patients start their study prescription
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxidative stress
Time Frame: at 0, 12, 24 week after patients start their study prescription
|
Oxidative stress will be assessed by Plasma OxLDL.
|
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
|
Inflammatory state will be assessed by C-reactive protein, pro-inflammatory cytokine levels (IL-6) and adipokines (leptin and adiponectin).
|
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
|
sICAM and sVCAM will be measured.
|
at 0, 12, 24 week after patients start their study prescription
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jie Dong, MD,PhD, Peking University First Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAPD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insulin Resistance
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedEndoplasmic Reticulum Stress | HIV Related Insulin Resistance | Protease Inhibitor Related Insulin ResistanceUnited States
-
German Diabetes CenterYale UniversityRecruiting
-
Paloma Almeda-ValdésCompleted
-
National Institute of Diabetes and Digestive and...Active, not recruitingSevere Insulin ResistanceUnited States
-
Eunice Kennedy Shriver National Institute of Child...Completed
-
National Taiwan UniversityNational Cheng-Kung University HospitalCompletedExercise, Insulin Resistance, Visceral Adipose TissueTaiwan
-
Assiut UniversityCompleted
-
University Health Network, TorontoCompletedInsulin Resistance Syndrome X | Pancreatic Beta Cell FunctionCanada
-
University of Colorado, DenverRecruitingEndothelial Dysfunction | Vascular Stiffness | Insulin Sensitivity/Resistance | TransgenderismUnited States
-
University of Texas, El PasoCompletedInsulin Sensitivity/ResistanceUnited States
Clinical Trials on Keto Acid
-
Peking Union Medical College HospitalUnknown
-
The Third Xiangya Hospital of Central South UniversityUnknownRenal Insufficiency, ChronicChina
-
Hospices Civils de LyonRecruiting
-
Sun Yat-sen UniversityCompleted
-
Gillette Children's Specialty HealthcareState of Minnesota Spinal Cord Injury and Traumatic Brain Injury Research... and other collaboratorsRecruitingTraumatic Brain InjuryUnited States
-
TRC GEN+ managed by Trans Russian co CyKGK Science Inc.CompletedHealthy | Ketogenic DietingCanada
-
KGK Science Inc.InterHealth Nutraceuticals, Inc.CompletedResting Metabolic Rate | Overweight SubjectsUnited States
-
Sun Yat-sen UniversityBeijing Fresenius Kabi Pharmaceutical CoCompletedRenal Function DisorderChina
-
Laureate Institute for Brain Research, Inc.RecruitingDepressionUnited States
-
University of AlbertaRecruitingDiabetes Mellitus, Type 2 | PreDiabetes | Overweight and ObesityCanada