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BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation (BetaFIT)

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ClinicalTrials.gov Identifier: NCT05622123
Recruitment Status : Recruiting
First Posted : November 18, 2022
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: 68Ga-NODAGA-Exendin-4 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Faecal Microbiota Transplantation on Beta Cell Preservation in Patients With Newly Diagnosed Type 1 Diabetes
Estimated Study Start Date : November 21, 2022
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05622123


Contacts
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Contact: Sevilay Tokgöz, PhD student +312455340 sevilay.tokgoz@radboudumc.nl
Contact: Martin Gotthardt, MD, Prof. martin.gotthardt@radboudumc.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Sevilay Tokgöz, PhD student    +312455340    sevilay.tokgoz@radboudumc.nl   
Sponsors and Collaborators
Radboud University Medical Center
Investigators
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Principal Investigator: Martin Gotthardt, MD, Prof. Radboud University Medical Center
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT05622123    
Other Study ID Numbers: NL81554.091.22
First Posted: November 18, 2022    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
Faecal microbiota transplantation
GLP-1 receptor
exendin
beta cell mass
beta cell function
imaging
microbiome
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists