Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Valsartan
Perindopril
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Anti-hypertensive drugs
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of chronic kidney disease
- Serum creatinine:1~3mg/dl
Exclusion Criteria:
- Diabetes
- Patients treated with corticosteroids or immunosuppressants
- BMI>30kg/m2
- SP>180mmHg, DP>110mmHg
- Patients with serious medical problems requiring specific medical treatment
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Valsartan
Perindopril
Arm Description
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Outcomes
Primary Outcome Measures
Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
HOMA-IR=FINS*FGLU/22.5
Secondary Outcome Measures
Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)
eGFR and CCR are calculated with MDRD formula
Body mass index(BMI)
BMI=weight/(height)^2
24-h urine protein, urinary albumin-creatinin ration, retinol binding protein
Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
Glycosylated hemoglobin
Full Information
NCT ID
NCT02299310
First Posted
November 20, 2014
Last Updated
November 29, 2014
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02299310
Brief Title
Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
Official Title
Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of valsartan and perindopril on HOMA-IR Index in patients with chronic kidney disease.
Detailed Description
eligiable volunteers are administrated single-dose over the period I and II (crossover) of Valsartan (80mg) as of Perindopril (4mg).
Every time before and after each medication, HOMA-IR index and other parameters and safety of Valsartan (80mg) and Perindopril (4mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic kidney disease, Anti-hypertensive drugs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Valsartan
Arm Type
Experimental
Arm Description
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Arm Title
Perindopril
Arm Type
Active Comparator
Arm Description
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Intervention Type
Drug
Intervention Name(s)
Valsartan
Other Intervention Name(s)
NOVARTIS
Intervention Description
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Intervention Type
Drug
Intervention Name(s)
Perindopril
Other Intervention Name(s)
ACERTIL
Intervention Description
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Primary Outcome Measure Information:
Title
Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
Description
HOMA-IR=FINS*FGLU/22.5
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)
Description
eGFR and CCR are calculated with MDRD formula
Time Frame
4 weeks
Title
Body mass index(BMI)
Description
BMI=weight/(height)^2
Time Frame
4 weeks
Title
24-h urine protein, urinary albumin-creatinin ration, retinol binding protein
Time Frame
4 weeks
Title
Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
Time Frame
4 weeks
Title
Glycosylated hemoglobin
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of chronic kidney disease
Serum creatinine:1~3mg/dl
Exclusion Criteria:
Diabetes
Patients treated with corticosteroids or immunosuppressants
BMI>30kg/m2
SP>180mmHg, DP>110mmHg
Patients with serious medical problems requiring specific medical treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RiBao Wei, Master
Phone
+861055499133
Email
wrbbj2006@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Wang, Master
Phone
+861055499133
Email
wrbbj2014@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RiBao Wei, Master
Organizational Affiliation
Department of Nephrology, Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25137874
Citation
Satirapoj B, Leelasiri K, Supasyndh O, Choovichian P. Short-term administration of an angiotensin II receptor blocker in patients with long-term hemodialysis patients improves insulin resistance. J Med Assoc Thai. 2014 Jun;97(6):574-81.
Results Reference
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PubMed Identifier
23195328
Citation
Ushijima K, Takuma M, Ando H, Ishikawa-Kobayashi E, Nozawa M, Maekawa T, Shiga T, Fujimura A. Effects of telmisartan and valsartan on insulin sensitivity in obese diabetic mice. Eur J Pharmacol. 2013 Jan 5;698(1-3):505-10. doi: 10.1016/j.ejphar.2012.11.022. Epub 2012 Nov 27.
Results Reference
background
PubMed Identifier
22045314
Citation
Iwashita M, Sakoda H, Kushiyama A, Fujishiro M, Ohno H, Nakatsu Y, Fukushima T, Kumamoto S, Tsuchiya Y, Kikuchi T, Kurihara H, Akazawa H, Komuro I, Kamata H, Nishimura F, Asano T. Valsartan, independently of AT1 receptor or PPARgamma, suppresses LPS-induced macrophage activation and improves insulin resistance in cocultured adipocytes. Am J Physiol Endocrinol Metab. 2012 Feb 1;302(3):E286-96. doi: 10.1152/ajpendo.00324.2011. Epub 2011 Nov 1.
Results Reference
background
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Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
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