Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Valsartan Valsartan 80mg/tablet, 1 tablet once daily (crossover) |
Drug: Valsartan
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
Other Names:
|
| Active Comparator: Perindopril Perindopril 4mg/tablet, 1 tablet once daily (crossover) |
Drug: Perindopril
Perindopril 4mg/tablet, 1 tablet once daily (crossover)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Homeostasis model of assessment for insulin resistence index (HOMA-IR index) [4 weeks]
HOMA-IR=FINS*FGLU/22.5
Secondary Outcome Measures
- Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR) [4 weeks]
eGFR and CCR are calculated with MDRD formula
- Body mass index(BMI) [4 weeks]
BMI=weight/(height)^2
- 24-h urine protein, urinary albumin-creatinin ration, retinol binding protein [4 weeks]
- Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein [4 weeks]
- Glycosylated hemoglobin [4 weeks]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese PLA General Hospital | Beijing | Beijing | China | 100853 |
Sponsors and Collaborators
- Chinese PLA General Hospital
Investigators
- Study Chair: RiBao Wei, Master, Department of Nephrology, Chinese PLA General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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 PPARĪ³, 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.
- 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.
- 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.
- S2014-088