Osaka Metropolitan Diabetes & Obesity Trial 1

JRCT ID: jRCT1051240017

Registered date:07/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 07/05/2024
• Target sample size: 50
• Study type: Interventional

Intervention(s)

arm A (control/non-treated group): current anti-diabetes treatment will continue for 16 weeks.
arm B (tirzepatide group): tirzepatide will be administered subcutaneously (s.c.) at a starting dose of 2.5 mg/week for 4 weeks, then at a maintenance dose of 5.0 mg/week for 12 weeks.
arm C: (semaglutide group): semaglutide will be administered s.c. at a starting dose of 0.25 mg/week for 4 weeks, then at a maintenance dose of 0.5~1.0 mg/week for 12 weeks.

Outcome(s)

• Primary Outcome: Changes in the composition, gene functions and pathways of gut microbiota by metagenomic analysis at 16 week

Secondary Outcome

1. Changes in the composition of gut microbiota over time (0, 4, 8, 12, 16 weeks)
2. Relationship between changes in clinical parameters (body weight, blood glucose/HbA1c, serum lipids, fatty liver index (FLI), urinary albumin-to-creatinine ratio (UACR), bone metabolism markers) and blood metabolites and changes in the composition/gene functions of gut microbiota
3. Differences in the gut microbiota composition/gene function changes between responders and non-responders for blood glucose/body weight after treatment.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Patients with type 2 diabetes attending the facility during the trial period
2. Age >= 20 years and <80 year at the time of signing informed consent
3. Diagnosed with type 2 diabetes at least 180 days prior to screeing
4. Currently treated with metformin
5. If receiving oral antihyperglycemic drugs other than metformin and/or insulin, the type of drugs has not changed for at least 3 months (changes in dosage of the same drug are allowed).
6. HbA1c >= 7.0% and <10% at screening
7. BMI >= 23 kg/m2 at screening and beeing stable within 5% for the past 3 months
8. Able to carry out stable diet and exercise therapy during the research period

Exclude criteria

1. History of type 1 diabetes
2. History of either chronic or acute pancreatitis
3. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy at screening
4. Any history or evidence of chronic liver disease other than metabolic dysfunction-associated fatty liver disease (MAFLD) or AST and/or ALT >3x upper limit of normal range
5. Impaired renal function, defined as eGFR <30 mL/min/1.73 m2 at screening
6. Pregnant women, those who may be pregnant, or those who are breastfeeding
7. History of autoimmune disease, history of inflammatory bowell disease, history of organ transplantation or awaiting an organ transplant, or confirmed diagnosis of malignancy within 5 years prior to screening.
8. Treatment with any medication for the indication of obesity (mazindol) within 3 months before screening
9. Treatment with incretin-related anti-diabetes drugs other than DPP-4 inhibitors, such as GLP-1R agonists (liraglutide, dulaglutide, lixisenatide, exenatide, semaglutide), GLP-1R/GIPR dual agonist (tirzepatide), within 3 months before screening
10. Treatment with alpha-glucosidase inhibitors for type 2 diabetes wihtin 3 months before screening
11. Treatment with glucocorticoid
12. Treatment with any antibiotics or antiviral drugs within 1 month before the date of fecal collection
13. Patients who are judged to be ineligible to be the subject of this trial by the investigators, e.g., patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled

Related Information

• Primary Sponsor: Emoto Masanori
• Secondary Sponsor: Uematsu Satoshi