BetaFIT study: Beta cell imaging after Faecal mIcrobiota Transplantation

BetaFIT study: Beta cell imaging after Faecal mIcrobiota Transplantation - BetaFIT study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53432

Enrollment

Registered

2022-07-11

Start date

2023-02-23

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type 1 diabetes

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Previously participated in ENCAPSULATE-DM1 or FMT preserve-DM1 trial • Type 1 diabetes • Age >= 18 years • BMI 18-30 kg/m2 • Insulin use

Exclusion criteria

Exclusion criteria: • Inability to provide written informed consent • Other medication use than insulin • Pregnancy or the wish to become pregnant within 1 month 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

Design outcomes

Primary

Measure	Time frame
The main study parameter is the correlation between beta cell mass and function after faecal microbiota transplantation in newly diagnosed T1D patients. Within 1 month after completed participation in the ENCAPSULATE-T1D or FMT preserve-T1D trial, beta cell mass will be measured using the 68Ga-NODAGA-exendin-4 tracer. Beta cell function is derived in the following previous studies: ENCAPSULATE-DM1 or FMT preserve-DM1 during the last visit.	—

Measure

Time frame

The main study parameter is the correlation between beta cell mass and function after faecal microbiota transplantation in newly diagnosed T1D patients. Within 1 month after completed participation in the ENCAPSULATE-T1D or FMT preserve-T1D trial, beta cell mass will be measured using the 68Ga-NODAGA-exendin-4 tracer. Beta cell function is derived in the following previous studies: ENCAPSULATE-DM1 or FMT preserve-DM1 during the last visit.

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Secondary

Measure	Time frame
Beta cell mass will be related to parameters derived in the ENCAPSULATE-DM1 or FMT preserve-DM1 study (e.g. immunity status, insulin sensitivity).	—

Countries

Netherlands

Outcome results