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Japanese

Sept. 27, 2023

July. 21, 2026

jRCT1031230368

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

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

Ohara Makoto

Showa Medical University Hospital

1-5-8 Hatanodai Shinagawa-ku Tokyo, Japan

+81-3-3784-8000

s6018@nms.ac.jp

Ohara Makoto

Showa Medical University Hospital

1-5-8 Hatanodai Shinagawa-ku Tokyo, Japan

+81-337848000

s6018@nms.ac.jp

Complete

Sept. 27, 2023

66

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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) 18 years and over

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

18age old over
No limit

Both

type 2 diabetes

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).

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

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

Showa Medical University Hospital
Showa Medical University Hospital

No

none

History of Changes

No Publication date
6 July. 21, 2026 (this page) Changes
5 June. 08, 2026 Detail Changes
4 Dec. 10, 2025 Detail Changes
3 Oct. 08, 2024 Detail Changes
2 Mar. 12, 2024 Detail Changes
1 Sept. 27, 2023 Detail