Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

Sponsor
Steno Diabetes Center Greenland
Study ID
NCT06264427
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Whole genome sequencing — GENETIC
    Screening for MODY diabetes. Diabetic treatment will be adjusted based on the participant's diabetic genotype.
  • VAGUS — DIAGNOSTIC_TEST
    To examine for Cardiovasculare Autonomic Neuropathy participants will be tested with the handheld Vagus device (Medicus Engineering, Aarhus, Denmark). Participants are instructed to perform three cardiovascular reflex tests (CARTs) after lying still in supine position for 5 minutes to record heart rate at rest. CARTs include supine-to-upright position, deep-breathing, and valsalva maneuver. From each CART the ratio based on the shortest and longest R-R-interval at predefined timepoints in the recording is used to assess the possibility of CAN
  • NightOwl — DIAGNOSTIC_TEST
    Participants will be examined for sleep apnea for 3 nights using the NightOwl (Ectosense, Belgium) device, which measuring Peripheral Arterial Tonometry (PAT) in the index finger. The results of the examination will is uploaded via the patient's smartphone to an online platform accessible to healthcare providers. Participants with signs of sleep apnea will receive a confirmatory cardiorespiratory monitoring using the Nox T3s (Noxturnal, ResMed), and the results will be compared.
  • CPAP — DEVICE
    Participants with an Apnea-Hypoapnea-Index above 30, or above 15 with symptoms of sleep apnea, will be offered treatment with continuous positive airway pressure (CPAP).

Study Details

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

Key Dates

First listed
Feb 20, 2024
Start date
Jul 15, 2022
Status verified
Feb 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention arm
    All participants will undergo examination for genom sequencing, diabetic complications and obstructive sleep apnea. Treatment for these conditions will not be randomized, but will be offered any participant who fulfills the excision treatment criteria

Primary Outcome Measure

Number of participants with MODY diabetes and their complication status [ Time Frame: Blood drawn at inclusion. Results for participants ready after approximately 6 months. ]

Central Contacts

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