HYA slows the elevation of postprandial blood glucose level in patients with type 1 diabetes.

JRCT ID: jRCTs051220104

Registered date:14/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 1 diabates
• Date of first enrollment: 21/12/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Taking HYA capsules before food load

Outcome(s)

• Primary Outcome: Difference of glucose level between before intervention and 90 min after meal

Secondary Outcome

(1) Differences in pre-interventional and postprandial glucose levels (30, 60, 120, 150, 180, 210, or 240 min after meal).
(2) Differences in pre-interventional and postprandial ratio of glucose level (30, 60, 90, 120, 150, 180, 210, or 240 min after meal).
(3) Area under the curve of pre-intervention and 240 min after food load glucose level.
(4) Below the ratio on 30, 60, 90, 120, 150, 180, 210, 240 min after meal:
(postprandial glucose level in HYA administration - preinterventional glucose level in HYA administration) / (postprandial glucose level in placebo administration - preinterventional glucose level in placebo administration)
(5) Number of adverse events/ratio of occurrence of adverse events (diarrhea, abdominal pain, hypoglycemia and other adverse events).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged 18 years or older at the time of consent acquisition.
2) Patients with Type 1 diabetes.
3) Patients treated with fast-acting insulin analog.
4) Patients for whom an adequate dose of fast-acting insulin for dietary load of analog can be predicted by a doctor.
5) Patients who can understand this study and can provide signed document of consent.

Exclude criteria

1) Patients treated with regular or faster-acting insulin.
2) Patients treated with diabetes drugs other than insulin preparations.
3) Patients treated with implanted medical devices such as pacemakers.
4) Patients using glucose monitoring device other than Free Style Libre.
5) Patients who cannot take capsules.
6) Patients with chronic symptoms affecting gastric emptying (upper abdominal pain, nausea, loss of appetite, abdominal bloating).
7) Patients using drugs that affect gastric emptying.
8) Patients using steroids (oral or injection).
9) Patients with history of gastrectomy.
10) Patients with uncontrolled endocrine disease.
11) Pregnancy.
12) Patients who are otherwise judged to be unsuitable by the investigator/research coordinator.

Related Information

• Primary Sponsor: Yasushi Furukawa
• Secondary Sponsor: Yuta Yamamoto
• Source(s) of Monetary Support: Noster Inc