RecruitingNot ApplicableNCT06264427

Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

Sponsor

Steno Diabetes Center Greenland

Enrollment

1,000 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2 Obstructive Sleep Apnea Obesity, Morbid Diabetic Neuropathies Diabetic Retinopathy MODY

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting detailed health, lifestyle, and genetic information from people in Greenland who have type 2 diabetes and/or severe obesity. The goal is to better understand how these conditions develop in this specific population, which has a distinct genetic background and lifestyle compared to other groups typically studied in medical research. **You may be eligible if...** - You are 18 or older - You have been diagnosed with type 2 diabetes and/or severe obesity (BMI over 40) - You speak English, Danish, or Greenlandic **You may NOT be eligible if...** - You do not have type 2 diabetes or severe obesity - You do not speak English, Danish, or Greenlandic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICWhole genome sequencing

Screening for MODY diabetes. Diabetic treatment will be adjusted based on the participant's diabetic genotype.

DIAGNOSTIC_TESTVAGUS

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

DIAGNOSTIC_TESTNightOwl

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.

DEVICECPAP

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).