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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan and metformin | Experimental |
| |
| Metformin only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan 80 mg and metformin | Drug | Valsartan 80 mg once daily in addition to metformin monotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum glycosylated hemoglobin A1c | Change in serum glycosylated hemoglobin A1c of the participants | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lipid fractions | Change in plasma triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol | 24 weeks |
| Blood pressure | Change in systolic blood pressure and diastolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Po-Chung Cheng, MD | Nantou Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantou Christian Hospital | Nantou City | Nantou County | 540001 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32175717 | 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. | |
| 30934934 | 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. |
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| Metformin | Drug | Metformin monotherapy |
|
| 24 weeks |
| 30371168 | 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. |
| 28191524 | 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. |
| 21738773 | 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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