BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

Phase 2

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Drug: 68Ga-NODAGA-Exendin-4

• Registration Number: NCT05622123
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The main goal is to investigate whether beta cell mass is correlated to beta cell function after autologous faecal microbial transplantation (FMT) in patients with newly diagnosed type 1 diabetes

Detailed Description

The incidence of Type 1 Diabetes Mellitus (T1D) has tripled in the last thirty years, and T1D is associated with a lifelong increase of considerable morbidity and mortality compared to healthy subjects. As the increased T1D incidence is primarily observed in subjects who are not genetically predisposed, environmental factors including altered diet, antibiotic use as well as mode of birth have been suggested to play a role, and these factors have invariably been linked to changes in the gut microbiome. Indeed, an altered composition of the faecal microbiota composition was observed in adolescent T1D patients. A previous study by de Groot et al. (2021) showed that faecal microbiota transplantation stops the decline in endogenous insulin production in newly diagnosed type 1 diabetes patients. However, it is unknown whether this is due to an increase in beta cell mass, or increased function of the remaining beta cells.

In this study, the investigators aim to investigate whether beta cell mass (quantified by 68Ga-NODAGA-exendin-4 PET/CT imaging) is correlated to beta cell function after autologous faecal microbial transplantation in patients with newly diagnosed type 1 diabetes.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-18
• Study Start: 2023-02-23
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-02-28
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Previously participated in ENCAPSULATE-DM1 or FMT preserve-DM1 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

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 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: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with type 1 diabetes who have completed the ENCAPSULATE-DM1 or FMT preserve-DM1 trial	68Ga-NODAGA-Exendin-4	PET/CT imaging after injection with 68Ga-NODAGA-exendin-4 to quantify beta cell mass

Primary Outcome Measures

Name	Time	Method
Correlation between residual beta cell mass and function	1 year	The correlation between residual beta cell mass measured with 68Ga-NODAGA-Exendin-4 PET/CT imaging at 12 ±1 months and beta cell function derived in the ENCAPSULATE-DM1 or FMT preserve-DM1

Secondary Outcome Measures

Name	Time	Method
Correlation with other parameters	1 year	Beta cell mass will be related to parameters derived in the ENCAPSULATE-DM1 or FMT preserve-DM1 study (e.g. immunity status, insulin sensitivity)

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands