The efficacy and safety of Tirzepatide for type 2 diabetes subjects with chronic kidney disease: prospective observational study
Not Applicable
Recruiting
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000051344
- Lead Sponsor
- Kushiro Red Cross Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subjects on erythropoietin stimulating agents or hypoxia-inducible factor-prolyl hydroxylase domain inhibitor 2) Subjects on maintenance hemodialysis or peritoneal dialysis 3) Subjects who are deemed to be unsuitable by the investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference of change in HbA1c after 24 weeks between the tirzepatide and control groups.
- Secondary Outcome Measures
Name Time Method The following changes at 4, 12, and 24 weeks from the beginning of the study 1) Body weight, body mass index, waist circumference and a body shape index 2) Total weight loss rate and excess weight loss rate 3) Blood pressure 4) Fasting plasma glucose 5) Other blood and urine tests (liver, kidney, lipid, bone metabolism, nutrition, endocrine, etc) 6) ABI, CAVI, and PWV in arteriosclerosis testing 7) Dual-energy X-ray absorptiometry 8) Body composition (InBody) 9) Total fat area including of visceral fat mass and subcutaneous fat mass (computed tomography), CT value of liver and spleen, L/S ratio 10) Hepatic steatosis and fibrosis index (calculation from blood tests) 11) the result and diagram from the Eating Behavior Questionnaire 12) the types and severity, etc., of adverse events reported