DRUG
68Ga-NODAGA-Exendin-4
PET/CT imaging after injection with 68Ga-NODAGA-exendin-4
Status
Unknown
Phase
Phase 2
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study 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
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
DRUG
PET/CT imaging after injection with 68Ga-NODAGA-exendin-4
Timeline
First posted
Nov 18, 2022
Study start
Feb 23, 2023
Primary completion
Feb 28, 2024
Study completion
Mar 30, 2024
Results posted
Not reported
Registry updated
Apr 4, 2023
Outcomes
Correlation between residual beta cell mass and function
Time frame · 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
Correlation with other parameters
Time frame · 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)
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
Study locations
Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Publications
No PMID-linked publications were present in this registry snapshot.
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