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NCT04707508 Clinical Trial

Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Investigating the Effect of Renin-Angiotensin System Inhibitors in Addition to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Prospective Open-label Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04707508
Other study ID # Y_106_0298
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2017
Est. completion date November 29, 2019

Study information
Verified date January 2021
Source Nantou Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date November 29, 2019
Est. primary completion date January 23, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 80 Years
Eligibility Inclusion Criteria: - adults over 21 years of age - clinically diagnosed type 2 diabetes mellitus - recipients of metformin monotherapy - compliance with prescriptions and dietary intervention Exclusion Criteria: - recipients of any second-line antidiabetic drug in addition to metformin - recipients of any antihypertensive medication before study enrollment - hemoglobin disorders - chronic kidney disease - thyroid dysfunction

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Valsartan 80 mg and metformin
Valsartan 80 mg once daily in addition to metformin monotherapy
• Metformin
Metformin monotherapy

Locations
Country Name City State
Taiwan Nantou Christian Hospital Nantou City Nantou County

Sponsors (1)
Lead Sponsor Collaborator
Nantou Christian Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Das UN. Renin-angiotensin-aldosterone system in insulin resistance and metabolic syndrome. J Transl Int Med. 2016 Jun 1;4(2):66-72. doi: 10.1515/jtim-2016-0022. Epub 2016 Jul 7. — View Citation

Joseph JJ, Echouffo Tcheugui JB, Effoe VS, Hsueh WA, Allison MA, Golden SH. Renin-Angiotensin-Aldosterone System, Glucose Metabolism and Incident Type 2 Diabetes Mellitus: MESA. J Am Heart Assoc. 2018 Sep 4;7(17):e009890. doi: 10.1161/JAHA.118.009890. — View Citation

Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001. — View Citation

Mor A, Aizman E, George J, Kloog Y. Ras inhibition induces insulin sensitivity and glucose uptake. PLoS One. 2011;6(6):e21712. doi: 10.1371/journal.pone.0021712. Epub 2011 Jun 29. — View Citation

Nehme A, Zouein FA, Zayeri ZD, Zibara K. An Update on the Tissue Renin Angiotensin System and Its Role in Physiology and Pathology. J Cardiovasc Dev Dis. 2019 Mar 29;6(2). pii: E14. doi: 10.3390/jcdd6020014. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Serum glycosylated hemoglobin A1c Change in serum glycosylated hemoglobin A1c of the participants 24 weeks
Secondary Plasma lipid fractions Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol 24 weeks
Secondary Blood pressure Change in systolic blood pressure and diastolic blood pressure 24 weeks
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