Investigation of the pathogenesis of type 1 and insulin-dependent diabetes mellitus using a noninvasive pancreatic beta cell imaging technique

JRCT ID: jRCT1051220023

Registered date:11/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 1 diabetes mellitus
• Date of first enrollment: 17/05/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

PET scanning for patients of Type 1 Diabetes Mellitus.
Test drug: [18F]-FB(ePEG12)12-Ex4
Dosage: 37-74 MBq, increase or decrease based on body weight and probe yield.
The amount of exenatide should be less than 10 micro grams.

Outcome(s)

• Primary Outcome: Pathophysiological analysis of type 1 diabetes mellitus by evaluating the relationship between the amount of pancreatic beta cells obtained by PET imaging and existing clinical indices.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Clinically diagnosed with type 1 diabetes mellitus or recognized as insulin-dependent diabetes mellitus
2) Aged 20 years or older at the time of the informed consent
3) Written consent has been obtained from the subject for participation in this study

Exclude criteria

1) Patients have severe liver or kidney dysfunction
2) Inability to discontinue GLP-1 related products
3) Patients who are unsuitable or contraindicated for exenatide administration
4) Patients with alcohol intolerance
5) Patients who were judged to be inappropriate for enrolment by the physician

Related Information

• Primary Sponsor: Murakami Takaaki
• Source(s) of Monetary Support: Manpei Suzuki International Prize for Diabetes Research