The process of implementing interventions and measuring research variables
T2D, high-density lipoprotein, hypoglycemic, ’ eating habits, Diabetes, TG, diabetes
DIABETES, COMPLICATIONS, DIABETES
The study was approved by the Isfahan University of Medical Sciences ethics committee (Approval no. IR.MUI.MED.REC.1397.230), and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all patients. The study protocol was registered at irct.ir as IRCT20171030037093N11 (Ninety two eligible patients were selected using convenience sampling method. Then, these patients were divided into two groups using random allocation software. At the beginning of the study, patients’ demographic and clinical information including sex, age, BMI, waist circumference (WC), systolic blood pressure (SBP), diastolic blood pressure (DBP), comorbidities, duration of T2D, history of drug use (lipid-lowering drugs, hypoglycemic drugs, and antihypertensive drugs), biochemical parameters including urine creatinine (Urine Cr), urine albumin (Urine Alb), UACR, Hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), serum creatinine and glomerular filtration rate (GFR) by MDRD formula, lipid profile including triglycerides (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol, and liver enzymes including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) were recorded.For all patients, a routine diabetes treatment was prescribed according to the standard protocol of American Diabetes association (ADA) statement. In addition, 5 mg of linagliptin was administered to patients in the intervention group for 24 weeks while patients in the control group received placebo for 24 weeks.It should be mentioned that in order to comply with the double-blind condition, linagliptin and placebo which had been already prepared by Alhavi Pharmaceutical Company, located in Tehran, Iran, in the same shape, size, and color. Starch had been used to make placebo tablets. The prepared drugs had been coded, and provided to the researcher. Therefore, the researcher, patients, the information evaluator, and the statistical analyst had no knowledge of the type of the intervention performed in the two groups.Furthermore, all patients were requested to follow the healthy dietary patterns and proper physical activity in the treatment process to control these factors as much as possible and prevent the disruptive effect of patients’ eating habits and physical activity on the results of the study.Patients were evaluated in terms of the complications of the medication two weeks after the beginning of the intervention and then every 4 weeks. In addition, patients’ anthropometric, blood pressure, and biochemical factors were assessed 12 weeks and 24 weeks after the intervention. To perform accurate measurements and evaluations, data collection was performed by a single specialist technician, and all biochemical tests were performed only in the Laboratory of Isfahan Endocrine and Metabolism Research Center.