Combination of SGLT2 inhibitor and Intensive Exercise in Diabetes.

JRCT ID: jRCTs071180050

Registered date:15/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 07/07/2016
• Target sample size: 146
• Countries of recruitment: none
• Study type: Interventional

Intervention(s)

1)Dapagliflozin monotherapy group
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.
2)Group which combines dapagliflozin and intensive physical exercise intervention
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,

Outcome(s)

• 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

Secondary Outcome(s)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.

Key inclusion & exclusion criteria

• Age minimum: 20 age old
• Age maximum: 75 age old
• Gender: Both

Include 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

Exclude criteria

1) Type 1 diabetic patients
2) Patients with a medical history of hypersensitivity to some ingredient(s) of the SGTL2 Inhibitor
3) Patients suffering from severe ketosis, diabetic coma, or precoma
4) Patients with severe infections, patients before or after operations or having severe external injuries
5) Patients with severe renal dysfunction, or patients with end-stage renal disease or those undergoing dialysis
6) Patients with severe liver dysfunction
7) Patients who are highly likely to suffer from dehydration
8) Patients with pituitary gland dysfunction or adrenal gland dysfunction
9)Patients in dystrophia conditions, starvation status, irregular meal intake, insufficient dietary intake, or extremely weakened state
10) Patients with an excessive alcohol consumption
11) Pregnant women, patients who might be pregnant, and lactating women
12) Patients with active infectious diseases
13) Patients with malignancies
14)Patients with active diabetic proliferative retinopathy
15) Patients with glucocorticoid
16) Patients with insulin
17)Patients who have experienced hypoglycemia 3 times or more, which requires a drug treatment such as instillation with glucose before recovery
18) Patients who are judged to be inadequate to participate in this study by a doctor in charge

Related Information

• Primary Sponsor: Yoshihiro Ogawa
• Source(s) of Monetary Support: Ono Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000020263