Current partner codePEPTIDESDE
NCT05622123·Phase 2·INTERVENTIONAL

BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

Status

Unknown

Phase

Phase 2

Enrollment

20

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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

Treatment arms and agents.

DRUG

68Ga-NODAGA-Exendin-4

PET/CT imaging after injection with 68Ga-NODAGA-exendin-4

Timeline

From registration to results.

  1. First posted

    Nov 18, 2022

  2. Study start

    Feb 23, 2023

  3. Primary completion

    Feb 28, 2024

  4. Study completion

    Mar 30, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Apr 4, 2023

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

Netherlands. Showing up to 24 locations stored in the fast local snapshot.

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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