BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Faecal Microbiota Transplantation on Beta Cell Preservation in Patients With Newly Diagnosed Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: 68Ga-NODAGA-Exendin-4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with type 1 diabetes who have completed the ENCAPSULATE-DM1 or FMT preserve-DM1 trial<br>PET/CT imaging after injection with 68Ga-NODAGA-exendin-4 to quantify beta cell mass | Drug: 68Ga-NODAGA-Exendin-4<br>* PET/CT imaging after injection with 68Ga-NODAGA-exendin-4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between residual beta cell mass and function | 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 | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Faecal microbiota transplantation, GLP-1 receptor, exendin, beta cell mass, beta cell function, imaging, microbiome