Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Valsartan and metformin
|
Drug: Valsartan 80 mg and metformin
Valsartan 80 mg once daily in addition to metformin monotherapy
|
| Active Comparator: Metformin only
|
Drug: Metformin
Metformin monotherapy
|
Outcome Measures
Primary Outcome Measures
- Serum glycosylated hemoglobin A1c [24 weeks]
Change in serum glycosylated hemoglobin A1c of the participants
Secondary Outcome Measures
- Plasma lipid fractions [24 weeks]
Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol
- Blood pressure [24 weeks]
Change in systolic blood pressure and diastolic blood pressure
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nantou Christian Hospital | Nantou City | Nantou County | Taiwan | 540001 |
Sponsors and Collaborators
- Nantou Christian Hospital
Investigators
- Principal Investigator: Po-Chung Cheng, MD, Nantou Christian Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Y_106_0298