Effect of Sodium Glucose Co-transporter 2 Inhibitor on Inflammatory Cytokine in Type 2 Diabetes
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      -  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.
    

Detailed description: 
      First among cardiovascular (CV) end point trials of glucose-lowering agents, the EMPA-REG
      OUTCOME trial-using 10 or 25 mg/day SGLT2 inhibitor empagliflozin against placebo in 7,020
      patients with T2DM who were at increased CV risk-reported a 14% reduction in major CV events
      and marked relative risk reductions in CV mortality (38%), hospitalization for heart failure
      (35%), and death from any cause (32%) over a median time period of 2.6 years. Though these
      results have raised the possibility that mechanisms other than those observed in the
      trial-modest improvement in glycemic control, small decrease in body weight, and persistent
      reductions in blood pressure and uric acid level-may be at play, it's not clearly known yet.

      The inflammatory nature of atherosclerosis is well established. We hypothesized that
      empagliflozin might have an inhibitory effect on inflammasome activity in macrophages, thus
      contribute to cardioprotective effects in diabetes.

        -  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

        -  Healthy volunteers : effect of 3 day-ketogenic diet on changes in cytokines, metabolites
           (IL-1beta, beta-hydroxybutyrate , etc) and inflammasome activity in macrophages
    

Intervention name(s): Glimepiride; Empagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): In accordance with the standard treatment guidelines of diabetes, glimepiride as a drug of active comparator will be administered to improve blood sugar in patients with poorly controlled blood sugar.; Empagliflozin as a drug of experimental will be administered to improve blood sugar in patients with poorly controlled blood sugar.
Other intervention name(s): Amaryl; Jardiance
Intervention MeSH terms: Empagliflozin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment