Clinical trial NCT02299310: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease, Anti-hypertensive drugs
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Homeostasis model of assessment for insulin resistence index (HOMA-IR index)
timeFrame: 4 weeks
Secondary outcomes:
measure: Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)
timeFrame: 4 weeks
measure: Body mass index(BMI)
timeFrame: 4 weeks
measure: 24-h urine protein, urinary albumin-creatinin ration, retinol binding protein
timeFrame: 4 weeks
measure: Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein
timeFrame: 4 weeks
measure: Glycosylated hemoglobin
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Department of Nephrology, Chinese PLA General Hospital
name: RiBao Wei, Master
role: STUDY_CHAIR
References:
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.
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.
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.