Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Effect of Valsartan vs Perindopril on HOMA-IR Index in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02299310
• Other study ID #: S2014-088
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 20, 2014
• Last updated: November 29, 2014
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Chinese PLA General Hospital
• Contact: RiBao Wei, Master
• Phone: +861055499133
• Email: wrbbj2006[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Valsartan
Valsartan 80mg/tablet, 1 tablet once daily (crossover)
• Perindopril
Perindopril 4mg/tablet, 1 tablet once daily (crossover)

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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 PPAR?, 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis model of assessment for insulin resistence index (HOMA-IR index)	HOMA-IR=FINS*FGLU/22.5	4 weeks	Yes
Secondary	Glomerular filtration rate(eGFR) and Creatinine clearance rate(CCR)	eGFR and CCR are calculated with MDRD formula	4 weeks	Yes
Secondary	Body mass index(BMI)	BMI=weight/(height)^2	4 weeks	Yes
Secondary	24-h urine protein, urinary albumin-creatinin ration, retinol binding protein		4 weeks	Yes
Secondary	Cholesterol, triglycerides, high density lipoprotein, low density lipoprotein		4 weeks	Yes
Secondary	Glycosylated hemoglobin		4 weeks	Yes