Role of TMEM219 Marker in Type 1 Diabetes

NCT03794739 | Unknown

• 1 other identifier: 2018/ST/080
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes (T1D) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. The different immunological approaches implemented to date to treat T1D have obtained a negligible number of insulin-independent individuals. The initial stages of diabetic disease are characterized by the massive and progressive infiltration of T cells and autoantibodies within the tissue with the consequent development of insulitis and subsequently, the destruction of pancreatic beta cells. The onset of T1D has been mainly associated to a dysregulation of the immune response. However, data are emerging on the importance of non-immunological factors responsible for the damage to pancreatic beta cells. The investigators have recently shown that the expression of the TMEM219 death factor is an essential factor in controlling the fate of stem cells in diabetes. The aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as TMEM219.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus; Beta cell loss; Beta cell apoptosis

Outcome Measures

Primary Outcomes (1)

• Altered TMEM219 expression in pancreatic islets/beta cells in diabetes.

  Change of TMEM219 expression in pancreatic islets/beta cells of healthy subjects as compared to that of individuals with type 1 diabetes (T1D), with type 2 diabetes (T2D) and of those at risk for developing the disease.

  1-24 months

Secondary Outcomes (2)

• Increased beta cell loss due to a dysregulated TMEM219 signaling in diabetes.

  25 months-48 months

• Altered TMEM219-peripheral regulating factors in diabetes.

  49 months-60 months

Study Arms (4)

Healthy subjects

Healthy subjects without diabetes, no recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit.

T1D individuals

Type 1 diabetic individuals with at least 3-year of duration of the disease. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit.

T2D individuals

Type 2 diabetic individuals with at least 5-year duration of the disease. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit.

AutoAb+ individuals

Individuals at risk for type 1 diabetes, with one or more autoantibody detected. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study already approved at the local Ethical Committee provides for the enrollment of the following groups of subjects: * subjects affected by diabetes (type 1, type 2, MODY) * subjects at risk of developing diabetes (positive screening for autoantibodies) * subjects not affected by diabetes Enrollment is coordinated by the University of Florida as part of the NPOD project, Network for the Pancreatic Organ Donors with Diabetes.

You may qualify if:

• Reported in the NPOD protocol

You may not qualify if:

• Reported in the NPOD protocol

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Pediatric Clinical Research Center

Milan, 20157, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, pancreatic sections, pancreatic islets.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Paolo Fiorina, MD, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca D'Addio, MD,PhD

CONTACT

+390250319820; francesca.daddio@unimi.it

Francesca D'Addio, MD, PhD

CONTACT

+390250319820; francesca.daddio@unimi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endocrinogy University of Milan, Director of Endocrinology and Diabetology Unit ASST Fatebenefratelli-Sacco

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 7, 2019
• Study Start: August 8, 2020
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

IT (1)