An Open label multi- facilities cooperation randomized control trial to verify methylglyoxal reductive effects of sitagliptin treatment in the type 2 diabetic patients

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2011
INTERVENTION: This study is a prospective randomized control trial. The entry period of this study is three years. Study subjects are poorly controlled type 2 diabetic patients. These patients are randomly assigned to two groups, an sitagliptin treatment group (sitagliptin 25mg/day) and other oral hypoglycemic agents treatment group. The dose of sitagliptin can be properly increased to 100 mg/day when the hypoglycemic effect is insufficient. Their height, body weight, blood pressure, serum creatinine, plasma methylglyoxal levels, urinary excretions of albumin, MCP‐1, 8‐OHdG, and AGT are determined before (baseline) and after the treatment for three months. We collect fasting blood and first urine samples in early morning. CONDITION: Poorly controlled type 2 diabetic patients. PRIMARY OUTCOME: percent change of plasma methylglyoxal level. SECONDARY OUTCOME: Percent changes in blood pressure, HbA1c, the urinary excretions of albumin, MCP‐1, 8‐OHdG and AGT. INCLUSION CRITERIA: The subjects enrolled in the present study are poorly glycemic controlled out‐patients with type 2 diabetes mellitus, who fulfill the following criteria; 1) poorly glycemic controlled defined as the HbA1c of more than 6.0%. 2) The medicine is not changed within the last three months, and the change of the medicine is not scheduled for the examination period (three months). 3) Serum creatinine is less than 2.5 mg/dl. 4) The participation agreement of this study is obtained.
Epistemonikos ID: 1799ee75e0434983fcb73f6671924bb1efb060fd
First added on: Aug 22, 2024