Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGValsartan 80 mg and metformin
Valsartan 80 mg once daily in addition to metformin monotherapy
DRUGMetformin
Metformin monotherapy
Sponsors
Nantou Christian Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum glycosylated hemoglobin A1c | 24 weeks | Change in serum glycosylated hemoglobin A1c of the participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed