Clinical trial

Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

Recruiting now · Not applicable · 1 countries · Registry ID NCT06264427

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

Inclusion Criteria: * Type 2 diabetes and/or morbid obesity (BMI \>40) * Over 18 years old Exclusion Criteria: * Does not speak either English, Danish or Greenlandic

Treatments and study arms

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).

Primary outcomes

Number of participants with MODY diabetes and their complication statusBlood drawn at inclusion. Results for participants ready after approximately 6 months.

What is the proportion of patients linked to care at SDCG who have MODY diabetes, and to what degree do they suffer from micro- and macrovascular complication.

Number of participants with diabetic complicationTypes and number of complications are available at inclusion. No follow-up screenings for complications are performed.

What is the proportion of participants with diabetes complication overall.

Number of participants with obstructive sleep apneaHome sleep testing is performed for 3 nights after inclusion. Confirmatory home sleep examinations performed one day after the initial sleep examination. In total, four days examinations time.

What proportion of participants suffer from OSA.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Steno Diabetes Center Greenland, Queen Ingrids Hospital🌐 Nuuk, Sermersooq, Greenland

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Mads Mose Jensen, MD.Contact

Email · Call +299 34 46 23

Marit Eika Jørgensen, Md. Ph.dContact

Email · Call 34 43 24