BetaFIT study: Beta cell imaging after Faecal mIcrobiota Transplantatio

Phase 2

Conditions: diabetes
type 1 diabetes
10018424

Registration Number: NL-OMON53432

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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

• 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 < 40 ml/min/1.73 m²

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>Beta cell mass will be related to parameters derived in the ENCAPSULATE-DM1 or<br /><br>FMT preserve-DM1 study (e.g. immunity status, insulin sensitivity).</p><br>