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Changes in Blood Sugar, Body Weight, Muscle Mass, and Body Fat During Tirzepatide Treatment in Patients With Type 2 Diabetes

Investigation of Changes in Clinical Parameters Associated With Treatment With Tirzepatide, a Novel Antidiabetic Agent - Tirzepatide Clinical Parameters Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000055262
Enrollment
20
Registered
2025-06-01
Start date
2023-04-17
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

None listed

Sponsors

Shinmatsudo Central General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes who received tirzepatide as part of routine clinical care at our hospital, had the required clinical data available at baseline and weeks 12, 24, and 48, and maintained unchanged background glucose-lowering therapy throughout the 48-week observation period. Switching from dulaglutide to tirzepatide at baseline was permitted.

Exclusion criteria

Exclusion criteria: Patients with advanced renal dysfunction, defined as an estimated glomerular filtration rate below 30 mL/min/1.73 m2, proliferative diabetic retinopathy, diabetic ketoacidosis, liver cirrhosis, uncontrolled endocrine disorders, active infections, malignancies, other serious systemic diseases, or sarcopenia according to the Asian Working Group for Sarcopenia 2019 criteria were excluded. Patients who remained on a lower tirzepatide dose for nonmedical reasons were also excluded from the retrospective analysis.

Design outcomes

Primary

MeasureTime frame
Change in glycated hemoglobin (HbA1c) from baseline to week 48.

Secondary

MeasureTime frame
Changes in body weight, body mass index, waist circumference, body fat mass, and muscle mass of the trunk, bilateral arms, and bilateral legs from baseline to weeks 12, 24, and 48; changes in continuous glucose monitoring metrics, including time in range, time above range, time below range, and coefficient of variation; changes in handgrip strength and performance on the five-times sit-to-stand test from baseline to week 48; and associations between percentage changes in body weight and regional muscle mass at week 48.

Countries

Japan

Contacts

Public ContactShiori Kojima

Shinmatsudo Central General Hospital Department of Endocrinology, Diabetes and Metabolism

kobatons@gmail.com0473451111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026