Trehalose study in type 1 diabetics and healthy adults

JRCT ID: jRCTs031240588

Registered date:27/12/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

Type 1 Diabetes
Healthy Adults

• Date of first enrollment: 27/12/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Trehalose 15g/day taken internally for 7 days

Outcome(s)

Primary Outcome

Changes in time in range (TIR) by continuous glucose monitoring (CGM) for one week before and during trehalose administration
Change (difference) A = 1 week of trehalose administration period - 1 week of previous observation period

Secondary Outcome

Difference between before and after TIR at 1 week post-treatment and at 1 week of the pre-treatment period
Change (difference) B = 1 week post-treatment - 1 week pre-treatment

Difference in TIR between 1 week post-treatment and 1 week during the trehalose treatment period
Change (difference) C = 1 week post-treatment - 1 week of trehalose administration period

Before and after TIR of 1 week post-trehalose administration period and 1 week preobservation period
Percentage change A = Change (difference) A / 1 week pre-treatment period * 100
Change in time above range (TAR) by CGM (difference A and rate A)
Change in Time below range (TBR) by CGM (Difference A and Rate A)
Change in mean blood glucose by CGM (difference A and rate A)
Change in C-peptide (Difference A and Rate A)
Change in HbA1c, glycoalbumin, 1,5-AG (difference A and rate A)
Change in total daily dose of insulin (difference A and rate A)

TIR before and after 1 week post-dose and 1 week pre-observation period
Rate of change B = change (difference) B / 1-week pre-treatment period * 100
Change in TAR by CGM (difference B and rate B)
Change in TBR by CGM (difference B and rate B)
Change in mean blood glucose by CGM (difference B and rate B)
Change in C-peptide (Difference B and Percentage B)
Change in HbA1c, glycoalbumin, and 1,5-AG (difference B and rate B)
Change in total daily dose of insulin (difference B and rate B)

TIR before and after 1 week post-dose and 1 week during trehalose administration
Rate of change C = change (difference) C / 1 week of trehalose administration period * 100
Change in TAR by CGM (difference C and rate C)
Change in TBR by CGM (difference C and rate C)
Change in mean blood glucose by CGM (difference C and rate C)
Change in C-peptide (difference C and rate C)
Change in HbA1c, glycoalbumin, and 1,5-AG (difference C and rate C)
Change in total daily dose of insulin (difference C and rate C)

* Time above range (TAR) is the percentage of time that blood glucose was 200 mg/dL or higher during the measurement period.
** Time below range (TBR) is the percentage of time during the measurement period that blood glucose was below 70 mg/dL.

(Healthy adults only)
HOMA-2bata, HOMA-2R

Frequency of adverse events, presence of hypoglycemia, presence of hyperglycemia

Key inclusion & exclusion criteria

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

Include criteria

Individuals who meet all of the following criteria can participate.
1) Patients with type 1 diabetes or healthy adults (with no history of diabetes and normal HbA1c and blood glucose levels)
2) Those who have been fully informed of the study, with full understanding, and have given their free and voluntary written consent to participate in the study
3) Male or female who are 18 years of age or older at the time consent is obtained
4) Thise who are considered by the principal investigator or subinvestigators to be able to comply with the protocol requirements

Exclude criteria

Individuals who meet any of the following criteria will not be eligible.
1) Individuals with a serious illness or other medical condition (including serious laboratory abnormalities) that, in the judgment of the principal investigator or subinvestigators, may affect the interpretation of data or safety or preclude safe protocol evaluation
2) Participation in another clinical trial within 30 days prior to obtaining consent
3) Indivisuals with a history of hypersensitivity to trehalose
4) Indivisuals with a history of significant drug hypersensitivity or allergic reactions, including anaphylaxis
5) Those who are unable to comply with the requirements and procedures of the study
6) Pregnant or lactating women, or those who may be or are planning to be pregnant
7) Those who are considered inappropriate by the principal investigator or subinvestigators
8) Indivisuals taking trehalose within 30 days from the time of screening
9) Eating dumplings or rice cakes containing trehalose multiple times a week
10) Those who are using systemic steroids, antibiotics, or intestinal medication
11) Those with an HbA1c of 10% or higher

Related Information

• Primary Sponsor: Sakurai Kenichi
• Source(s) of Monetary Support: Chiba University Hospital