BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

Type 1 Diabetes Clinical Trial

— BetaFIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622123
• Other study ID #: NL81554.091.22
• Status: Recruiting
• Phase: Phase 2
• Start date: February 23, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: November 2022
• Source: Radboud University Medical Center
• Contact: Sevilay Tokgöz, PhD student
• Phone: +312455340
• Email: sevilay.tokgoz[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• 68Ga-NODAGA-Exendin-4
PET/CT imaging after injection with 68Ga-NODAGA-exendin-4

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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