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

Effect of HYA on slowing elevation of postprandial blood glucose level in patients with type 1 diabetes: a randomized, single site, single-blind, placebo-controlled crossover trial. - T1DM-HYA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051220104

Enrollment

Registered

2022-10-14

Start date

2022-12-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabates

Interventions

Taking HYA capsules before food load

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Difference of glucose level between before intervention and 90 min after meal	—

Secondary

Measure	Time frame
(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).	—

Measure

Time frame

(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).

—

Contacts

Public ContactYamamoto Yuta

Wakayama Medical University

yuta-y@wakayama-med.ac.jp+81-73-447-2300

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026