A Study on the Evaluation and Examination of Orthostatic Hypotension in Type 2 Diabetes Patients Based on Lower Limb Muscle Mass

JRCT ID: jRCT1040230044

Registered date:24/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients with type 2 diabetes
• Date of first enrollment: 24/06/2023
• Target sample size: 15
• Study type: Observational

Outcome(s)

• Primary Outcome: This is the relationship between blood pressure change during standing and muscle mass at admission, at discharge, and 3 months after discharge

Secondary Outcome

Change in HbA1c at admission and 3 months after discharge
Comparison of questionnaires on diabetes self-management at admission and 3 months after discharge
Comparison of questionnaires on subjective symptoms on standing at admission, at discharge, and 3 months after discharge
Cardiac output, heart rate, R-R interval

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 70age old
• Gender: Both

Include criteria

Persons with underlying disease, etc.
Disease: Type 2 diabetes
Gender: Male, Female
Age: 20 to 70 years old
Independent in daily living
Persons who can abstain from alcohol consumption and smoking on the day of the study
Persons who have obtained permission to participate in the study from their attending physician.
Persons who, after receiving an explanation of their participation in the study, have obtained written consent of their own free will based on a thorough understanding of the study.
Translated with www.DeepL.com/Translator (free version)

Exclude criteria

Medications being taken (drugs affecting the autonomic nervous system, tranquilizers, psychostimulants, levodopa and other drugs for the treatment of Parkinson's disease, antihypertensive drugs, vasodilators, etc.)
Persons deemed inappropriate as research subjects by the principal investigator

Related Information

• Primary Sponsor: Takeno Yukari
• Source(s) of Monetary Support: This research was financially supported by the JST Next Generation Researcher Challenging Research Program JPMJSP2125 of the Tokai National University Organization.