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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 vildagliptin

Randomized prospective study to investigate the association between intestinal FDG accumulation on 18F-FDG-PET/MRI and various parameters in patients taking metformin or vildagliptin - Study to investigate the association between intestinal FDG accumulation on PET/MRI and various parameters in patients taking metformin or vildagliptin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044969
Enrollment
40
Registered
2021-08-01
Start date
2021-10-01
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 2 diabetes

Interventions

After taking metformin or vildagliptin for 12 weeks, PET/MRI is taken Blood tests are performed monthly and feces are collected before and after treatment

Sponsors

Kobe university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Type 2 diabetes 2.20-75 years old 3.Patients who are judged by the attending physician to be required to receive metformin or vildagliptin 4.Patients who showed an understanding of the medication method in this study 5.Patients who have obtained written consent from the person 6.Patients who have only diet/exercise therapy for diabetes treatment within the last month

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Changes in glycemic control, weight, and abdominal circumference before and after treatment

Countries

Japan

Contacts

Public ContactKazuhiko Sakaguchi

Kobe university Department of Diabetes and Endocrinology

kzhkskgc@med.kobe-u.ac.jp078-382-5861

Outcome results

None listed

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