Type 2 diabetes diabetes
Conditions
Interventions
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
Sponsors
Emoto Masanori
Uematsu Satoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with type 2 diabetes attending the facility during the trial period 2. Age >= 20 years and = 7.0% and = 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the composition, gene functions and pathways of gut microbiota by metagenomic analysis at 16 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactTomoaki Morioka
Department of Metabolism, Endocrinology, and Molecular Medicine, Osaka Metropolitan University Graduate School of Medicine
Outcome results
None listed