Randomized prospective study to investigate the association between intestinal FDG accumulation obtained using 18F-FDG-PET/MRI and various parameters in patients taking metformin or vildaglipti
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000044969
- Lead Sponsor
- Kobe university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Not provided
1.Patients who are pregnant or breastfeeding and may become pregnant 2.Patients with a history of skin lesions with oral hypoglycemic agents or insulin 3.Patients with type 1 diabetes, including slowly progressive type, or other types of diabetes 4.Severe liver dysfunction 5.Severe renal dysfunction 6.Patients with severe cardiac dysfunction 7.Users of alpha glucosidase inhibitors, DPP4 inhibitors, SGLT2 inhibitors, and GLP1 receptor agonists within 1 month 8.Patients who have used antibiotics or antiparasitics within 1 month 9.Patients who used laxatives within 1 month 10.Patients who took PPI, corticosteroids, and immunosuppressive drugs within 1 month 11.Gastrointestinal diseases 12.Patients who have had gastrointestinal surgery in the past 13.Patients with new or recurrent malignancies within 1 year 14.Patients who are judged by the attending physician to have a mental illness 15.Patients who have internal implants 16.Others who are judged by researchers to be unsuitable for this research 17.Patients who are judged by the attending physician to be in acute metabolic ataxia 18.Patients who are judged to be unsuitable for taking the study drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of semi-quantitative evaluation (SUVmean) of FDG accumulation at each site of the intestinal tract in the metformin group and vildagliptin group analyzed using 18F-FDG-PET/MRI 12 weeks after the start of treatment
- Secondary Outcome Measures
Name Time Method Changes in glycemic control, weight, and abdominal circumference before and after treatment