Type 1 diabetes
Conditions
Sponsors
Radboud university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Previously participated in ENCAPSULATE-DM1, FMT preserve-DM1, or DIMID trial • Type 1 diabetes with the diagnosis being made in the last 4.5 years • Presence of at least one autoantibody associated with type 1 diabetes (anti-GAD-65, anti-IA2, islet cell antibodies, insulin autoantibodies) • Age = 18 years • BMI 18-30 kg/m2 • Insulin use Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Inability to provide written informed consent • Other medication use than insulin • Smoking • Evidence of compromised immunity • Presence of a second autoimmune disease (other than type 1 diabetes); e.g. celiac disease, hyper- or hypothyroidism, inflammatory bowel disease. Vitiligo is allowed. • Pregnancy or the wish to become pregnant within 6 months after the study • Breastfeeding • Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range • Renal disease defined as MDRD < 40 ml/min/1.73 m²
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate whether autologous faecal microbiota transplantation (FMT) in patients with newly diagnosed type 1 diabetes (<100 days) preserves residual beta cell function and mass after 12 months;Secondary Objective: Beta cell mass will be related to parameters derived in the ENCAPSULATE-DM1, FMT preserve-DM1, or DIMID study such as beta cell function and immunity status;Primary end point(s): The primary endpoint is to determine residual beta cell mass using 68Ga-NODAGA-exendin-4 tracer in patients received faceal microbiota transplantation during the ENCAPSULATE-DM1, FMT preserve-DM1, or DIMID trial.;Timepoint(s) of evaluation of this end point: after the administration of the tracer and the PET/CT scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Beta cell mass will be related to parameters derived in the ENCAPSULATE-DM1, FMT preserve-DM1, or DIMID study such as beta cell function and immunity status;Timepoint(s) of evaluation of this end point: After the PET/CT scan en analyses of all parameters. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Nuclear Medicine
Radboud university medical center
Outcome results
None listed