Type 1 Diabetes
Conditions
Keywords
Faecal microbiota transplantation, GLP-1 receptor, exendin, beta cell mass, beta cell function, imaging, microbiome
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.
Interventions
DRUG68Ga-NODAGA-Exendin-4
PET/CT imaging after injection with 68Ga-NODAGA-exendin-4
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Netherlands
Contacts
Primary ContactSevilay Tokgöz, PhD student
Backup ContactMartin Gotthardt, MD, Prof.
Outcome results
None listed