Viewing Study NCT06264427



Ignite Creation Date: 2024-05-06 @ 8:08 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06264427
Status: RECRUITING
Last Update Posted: 2024-02-20
First Post: 2024-01-17

Brief Title: Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland
Sponsor: Steno Diabetes Center Greenland
Organization: Steno Diabetes Center Greenland

Study Overview

Official Title: Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland

The main questions it aims to answer are

Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes
Can genotyping and thereby personalized medicine be implemented in Greenland and can personalized medicine lead to improved treatment
What is the prevalence of sleep apnea among high-risk individuals in Greenland
Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea

Participants will

Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness
Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy
Clinical examination of height weight circumference of hip waist and neck Friedman tonsil and tongue score nasal air flow nasal septal deviation
Blood samples for full genome sequencing
Detailed Description: The phenotypic and genotypic characteristics of dysmetabolism in the Greenlandic Inuit population are yet to be described in detail However the unique interaction of genetic and environmental factors in this population and its effect on disease development calls for further investigation Therefore we aim to examine how metabolic diseases manifest and progress distinctively in this population compared to Western populations

The study employs whole genome sequencing with a focus on identifying variants in the TBC1D4 gene which is linked to muscular insulin resistance and HNF1α associated with MODY Maturity-onset Diabetes of the Young diabetes In addition the prevalence of Obstructive Sleep Apnea OSA in relation to metabolic disorders is examined Our methodology combines genetic analysis with clinical evaluations to understand the impact of these genetic factors on disease manifestation and potential complications

The findings will likely offer a unique perspective on the genetic influence on metabolic diseases in the Greenlandic Inuit population highlighting the significance of novel genetic variants for disease management and prevention The study investigates the relationship between metabolic disorders and OSA and aims to describe how diagnosis and treatment of OSA can be introduced in an Arctic setting This research emphasizes the need for genotype-aware treatment approaches and culturally tailored healthcare strategies not only for the Greenlandic Inuit but also as a model for personalized medicine approaches in other populations The insights gained here contribute to a deeper understanding of metabolic diseases potentially influencing future global healthcare strategies

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None