Dose setting test of insulin secretion inhibitor.

JRCT ID: jRCTs071200028

Registered date:28/08/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Visceral obesity with hyperinsulinemia.
• Date of first enrollment: 19/09/2020
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Oral administration of serial doses of diazoxide.

Outcome(s)

Primary Outcome

Adverse events and side effects.
Suppression of excessive insulin secretion without hyperglycemia.

• Secondary Outcome: Body weight loss. Shortening of waist length.

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1. Visiting Tomishiro Central Hospital at the Diabetes and Lifestyle Disease Center.
2. Written informed consent.
3. Waist length is more than 85cm of male or 90cm of female.

• Exclude criteria: Diabetes mellitus. Pt of Heart, Lung, Liver, Kidney or GI disease. Subjects of pregnancy or of allergy against diazoxide.

Related Information

• Primary Sponsor: Moritake Higa
• Source(s) of Monetary Support: OrphanPacific, Inc.