Combination Therapy of SGLT2 Inhibitor and intensive Physical Exercises, focusing on the Prevention of Muscle Mass Reduction in Patients with Type 2 Diabetes

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2015
INTERVENTION: Five mg of dapagliflozin is to be administered orally once a day for 24 weeks, and walking of 6000 steps or more per day is practiced. Five mg of dapagliflozin is to be administered orally once a day for 24 weeks, and walking of 8000 steps or more per day is practiced. Physical exercise of a medium strength (3.0 Mets) is carried out for 30 min or longer per day. In addition, as a resistance physical exercise, physical exercises of 6 items with 10 times x 3 sets are practiced per day as a target, CONDITION: Type 2 diabetes patients PRIMARY OUTCOME: Change in fat free mass at 24 weeks from the base line after the administration of dapagliflozin administration with intensive exercise therapy. SECONDARY OUTCOME: Change in the following markers at 24 weeks from the base line after the administration of dapagliflozin administration with intensive exercise therapy.; 1) HbA1c; 2) Serum adiponectin; 3) Leptin; 4) IL‐6; 5) high‐sensitive TNF‐alpha; 6) High sensitivity CRP; 7) Body weight; 8) Blood pressure; 9) The urinary albumin‐to‐creatinine ratio; 10) An implementation rate and degree of an exercize therapy 1,The number of steps 2,Activity time of 3.0 Mets or more 3,The number of implementation times of the resistance exercize and the number of sets.Only the groupe concomitantly performing the intensive exercize. INCLUSION CRITERIA: 1)Type 2 diabetic patients with age of 20 years old or older but below 75 years old 2)Patients whose BMI is 18.5 kg/m2 or higher but below 35.0 kg/m2 3)Patients whose HbA1c is 6.5% or higher but below10.0% (examination values of week 0 are to be applicable) 4)Patients whose eGFR is 45 mL/min/1.73 m2 or higher 5)Patients who have been receiving medications without any change in the administration and dosage for more than 8 weeks prior to the registration 6)Patients who can abide by the designated dietary treatment and exercise therapy 7)Patients from whom a consent in writing for the participation in this study has been obtained in person
Epistemonikos ID: b32a13752cee3bffe5eb87e685aa9cb8341d378f
First added on: Aug 23, 2024