Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland

NCT06264427 | Recruiting

• 1 other identifier: KVUG - 2022 - 10
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Number of participants with MODY diabetes and their complication status

  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.

  Blood drawn at inclusion. Results for participants ready after approximately 6 months.

• Number of participants with diabetic complication

  What is the proportion of participants with diabetes complication overall.

  Types and number of complications are available at inclusion. No follow-up screenings for complications are performed.

• Number of participants with obstructive sleep apnea

  What proportion of participants suffer from OSA.

  Home 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.

Secondary Outcomes (3)

• CPAP compliance in Greenlandic patients

  CPAP compliance is evaluated 6 months after treatment initiation.

• CPAP treatment effect on quality of life measured with the World Health Organization Well-being Index (WHO-5).

  The questionnaire is answered at inclusion and 6 months after.

• CPAP treatment effect on daytime sleepiness measured with the functional outcome of sleep questionnaire (FOSQ-10).

  The questionnaire is answered at inclusion and 6 months after.

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Genetic: Whole genome sequencing; Diagnostic Test: VAGUS; Diagnostic Test: NightOwl; Device: CPAP

Interventions

Whole genome sequencing GENETIC

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

Intervention arm

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

Intervention arm

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.

Intervention arm

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).

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes and/or morbid obesity (BMI \>40)
• Over 18 years old

You may not qualify if:

• Does not speak either English, Danish or Greenlandic

Sponsors & Collaborators

• Steno Diabetes Center Greenland: lead
• Zealand University Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Steno Diabetes Center Greenland, Queen Ingrids Hospital

Nuuk, Sermersooq, 3900, Greenland

RECRUITING

MeSH Terms

Conditions

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

Interventions

Whole Genome Sequencing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis, DNA; Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Marit Eika Jørgensen, Md. Phd

  Steno Diabetes Center Greenland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mads Jensen, MD.

CONTACT

+299 34 46 23; MMSN@peqqik.gl

Marit Eika Jørgensen, MD. Ph.d

CONTACT

+299 34 43 24; MAEJ@peqqik.gl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be examined with whole genom sequencing, and diabetes treatment will be accommodated their diabetic fenotype. 'For the intervention, participants will be screened for obstructive sleep apnea (OSA). Participants with signs of OSA will be offered treatment with Continuos Positive Airway Pressure.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 20, 2024
• Study Start: July 15, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Study protocol will be published in first quarter of 2024. Analytic code will be published in final peer reviewed articles alongside results of the study.
• Access Criteria: Ethical permission from Science Ethical Committee Approval from Health Authorities, Queen Ingrids Hospital Data Sharing Agreement

Locations

GR (1)