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Clinical Trials/JPRN-jRCTs071180050
JPRN-jRCTs071180050
Active, not recruiting
未知

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

Yoshihiro Ogawa0 sites146 target enrollmentMarch 15, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Yoshihiro Ogawa
Enrollment
146
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 15, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Yoshihiro Ogawa

Eligibility Criteria

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

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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