Type2 Diabetes Mellitus Clinical Trial
NCT number | NCT02964572 |
Other study ID # | 4-2016-0795 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | July 2017 |
Verified date | August 2020 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- Single-center, prospective, active-controlled, open, randomized, 2 arm parallel,
interventional, exploratory pilot
- Type 2 diabetic patients with high cardiovascular risks who have inadequate glycaemic
control with metformin-based oral hypoglycemic agents will be prescribed glimepiride
(comparison group) or empagliflozin (study group) for 60 days (plus or minus 32 days) as
add-on therapy
- Changes in IL-1beta secretion, serum beta-hydroxybutyrate concentration, and NLRP3
inflammasome activity from baseline to final timepoint will be assessed.
Status | Completed |
Enrollment | 61 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age =19 years - inadequate glycaemic control : HbA1c =6.5% or fasting glucose >120 mg/dl or random glucose >180 mg/dl - High risk of cardiovascular events defined as the presence of =1 of the following: 1. History of myocardial infarction 2. Evidence of multi-vessel coronary artery disease 3. Evidence of single-vessel coronary artery disease with a positive non-invasive stress test for ischemia or history of hospitalization for unstable angina 4. History of stroke 5. Evidence of occlusive peripheral artery disease 6. Evidence of carotid atherosclerosis 7. Metabolic syndrome - Healthy volunteers Exclusion Criteria: - Type 1 diabetes - Organ transplantation - Pregnant women - eGFR <45 - Cortisol or growth hormone deficiency, pituitary diseases - Gastric surgery - Hematologic disorders - Active cancers |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in the secretion of IL-1 beta from peripheral blood mononuclear cells | The effect of empagliflozin on the secretion of IL-1beta from peripheral blood mononuclear cells | Day 60 | |
Secondary | Changes in the secretion of TNF-alpha from peripheral blood mononuclear cells, before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of beta-hydroxybutyrate, before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in body weight (kg), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of insulin (µU/mL), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of glucagon (pg/mL), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of free fatty acid (µEq/L), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum glycated albumin (%), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of glucose (mg/dL), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of uric acid (mg/dL), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of liver enzymes (aspartate aminotransferase and alanine aminotransferase (IU/L)), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol (mg/dL)), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in serum concentrations of creatinine (mg/dL), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in spot urine concentrations of glucose (mg/dL) and creatinine (mg/dL) (those will be combined to report spot urine glucose-to-creatinine ratio in mg/mg), before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in mRNA expression level (PCR, fold) of IL-1beta, TNF-alpha, and NLRP3 in peripheral blood mononuclear cells, before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days | ||
Secondary | Changes in protein expression pattern (western blot, relative to control) of IL-1beta, TNF-alpha, and NLRP3 in peripheral blood mononuclear cells, before and after the administration of empagliflozin or glimepiride | Day 60 plus or minus 32 days |
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