drugset / Trial / NCT04707508
Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-12-01
- Primary completion
- 2019-01-23
- Completion
- 2019-11-29
Publications
- Background 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.
- Background 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):14. doi: 10.3390/jcdd6020014.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valsartan | Small molecule | 80 mg | — |
| Comparator | Metformin | Small molecule | — | — |