Imaging Pathophysiology Study of Whole Body Mitochondrial Function in Diabetic Patients

JRCT ID: jRCT1041240072

Registered date:20/08/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

diabetic
a healthy person

• Date of first enrollment: 20/08/2024
• Target sample size: 55
• Study type: Interventional
• Intervention(s): Whole body PET measurements using PET tracer in diabetic and healthy subjects to compare mitochondrial activity based on differences in tracer accumulation in brain, organs and tissues in the two groups.

Outcome(s)

• Primary Outcome: Differences in the distribution of [18F]BCPP-EF accumulation in systemic organ tissues, including the brain, between diabetic and healthy subjects.

Secondary Outcome

[18F]BCPP-EF accumulation in systemic organ tissues
Background information, 75g OGTT, continuous blood glucose measurement, physical findings, MRI images, neuropsychological examination, clinical laboratory tests, and relationship between NIRS-TRS

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Healthy persons
1. persons between the ages of 40 and 80 years old
2. Healthy subjects with no history or current history of metabolic, cardiac, or cerebrovascular diseases requiring medical treatment.
3. Persons who have given their consent to participate in this study by signing a consent form.

Patients with type 2 diabetes
1.Patients who are between 40 and 80 years old. 2.
2.Patients whose HbA1c is 6.5% or higher. 3.
3. Fasting blood glucose of 126 mg/dL or more or 2-hour blood glucose of 200 mg/dL or more. 4.
4. Patients who have agreed to participate in this study by signing a consent form in person.

Exclude criteria

1. healthy people who need to take medication (regular or irregular) that may alter glucose metabolism
2. Women who are pregnant or may become pregnant
3. women who are breastfeeding
4. patients with claustrophobia
5. those with contraindications to MRI (e.g., pacemakers, metals in the body, tattoos)
6. patients with mitochondrial disease, severe liver disease, renal disease, cardiac disease, or cerebrovascular disease
7. who have participated in other nuclear medicine research within one year from the time consent was obtained
8. Other subjects who are judged by the physician to be inappropriate as research subjects.

Related Information

• Primary Sponsor: Tsuriya Daisuke
• Source(s) of Monetary Support: Hamamatsu Photonics K.K.