臨床研究等提出・公開システム

Effects of Standard Treatment for High Triglycerides on Microcirculation

Triglyceride and Microcirculation (TG-MIC Study)

Yasu Takanori

Dokkyo Medical University Nikko Medical Center

145-1 Moritomo, Nikko City, Tochigi, Japan.

tyasu@dokkyomed.ac.jp

Yoshizawa Keiko

Dokkyo Medical University Nikko Medical Center

145-1 Moritomo, Nikko City, Tochigi, Japan.

+81-288-23-7000

kyoshi@dokkyomed.ac.jp

Recruiting

April. 28, 2025

Observational

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

Patients who are currently attending or scheduled to attend outpatient clinics at Dokkyo Medical University Nikko Medical Center.
Patients who are 18 years or older at the time of consent.
Patients who have had fasting triglycerides of 150 mg/dl or higher, or random triglycerides of 175 mg/dl or higher at least once between 24 weeks before and at the time of consent, and have started standard treatment with SPPARM or fibrate drugs.
Patients who have provided written consent to participate in the study.

Individuals who have previously taken SPPARM or fibrate drugs and experienced moderate or severe side effects.
Individuals who are unable to make decisions on their own due to dementia or other conditions.
Individuals deemed unsuitable for participation in the study by the principal investigator or co-investigator.

hypertriglyceridemia

Type Diabetes Mellitus,Metabolic Syndrome

D015228

Changes in the baseline values of capillary arterial blood flow velocity at rest and during reactive hyperemia, which are fingertip microcirculation parameters, from the start of standard treatment with SPPARM or fibrate drugs to 12 weeks later.

Changes or change rates from baseline to 12 weeks later in fingertip microcirculation parameters (vascular density and diameter at rest and during reactive hyperemia), fibrinogen, triglycerides, BAP, d-ROM, FFA, RLP-C, and blood fluidity.

+81-288237000

Mar. 26, 2025

Yes

The record will be replaced by the description in the research protocol. In accordance with Article 8-3 of the "Ethical Guidelines for Life Sciences and Medical Research Involving Human Subjects," the specified retention period must be strictly observed. (Three years from the date of provision for multi-center studies, and five years from the date of reporting the completion of the study for studies receiving the provision.) Informed consent in writing will be obtained from the individual. The data will be provided via electronic distribution.

none