Effect of tirzepatide on oxidative stress and glucose variability in patients with type 2 diabetes mellitus

JRCT ID: jRCT1031230368

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 05/03/2024
• Target sample size: 66
• Study type: Interventional

Intervention(s)

Continue GLP-1 receptor agonists (regular dose) or switch to tirzepatide.
Participants in the tirzepatide group follow an escalation regimen of 5mg tirzepatide once weekly (maintenance dose reached after 4 weeks of 2.5 mg tirzepatide once weekly).

Outcome(s)

• Primary Outcome: The primary end point was d-ROMs change from baseline after completing 24 weeks of treatment intervention.

Secondary Outcome

1) The change in glucose variability at 24 weeks from baseline
2) Glucose metabolism index, lipid metabolism index, Renal function, liver function
3) Eating Behavior Questionnaire and DTSQ
4) Blood pressure, pulse, weight

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

a diagnosis of type 2 diabetes mellitus
1) HbA1c 7.0% or more
2) Patients who were treated with regular doses of weekly GLP-1 receptor agonists at least for 12 weeks
3) BMI >= 23
4) written informed consent
5) 20 years and over

Exclude criteria

1)the use of steroids or anti-inflammatory drugs,
2)diabetic ketosis and coma within 3 months before the study,
3)severe infection, severe trauma, pre-and post-operation,
4)an estimated glomerular filtration rate are within 30mL/min/1.73m2,
5)malignancy,
6)pregnancy
7)Patients who are judged as inappropriate for inclusion by phsicians
8)Patients using implantable medical devices such as cardiac pacemakers

Related Information

• Primary Sponsor: Ohara Makoto