Diabetes Mellitus, Type 2NCT06264427
Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland
A study testing Whole genome sequencing, VAGUS and NightOwl in people with Diabetes Mellitus, Type 2 and Obesity, Morbid, run by Steno Diabetes Center Greenland at 1 site in Greenland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Morbid, Obstructive Sleep Apnea
- What is being tested?
- Whole genome sequencing, VAGUS and NightOwl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGreenland
- Study dates
- 15 Jul 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes and/or morbid obesity (BMI >40)
- Over 18 years old
Who cannot join
- Does not speak either English, Danish or Greenlandic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greenland1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Greenland, Queen Ingrids Hospital
Nuuk, Sermersooq, 3900
Mads Mose Jensen, MD., +299 34 46 23, MMSN@peqqik.gl
Marit Eika Jørgensen, Md. Ph.d, 34 43 24, MAEJ@peqqik.gl
About this study
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:
Read more
- 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
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Morbid, Obstructive Sleep Apnea, MODY, Diabetic Retinopathy, Diabetic Neuropathies
- Being tested
- Whole genome sequencing, VAGUS, NightOwl, CPAP
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Morbid, Sleep Apnea, Obstructive, Diabetic Retinopathy, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole genome sequencingGenetic
Screening for MODY diabetes. Diabetic treatment will be adjusted based on the participant's diabetic genotype.
VAGUSDiagnostic 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
NightOwlDiagnostic 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.
CPAPDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: Whole genome sequencing; Diagnostic Test: VAGUS; Diagnostic Test: NightOwl; Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Is it possible to develop and implement a specialized treatment regime for obstructive sleep apnea in Greenland with similar treatment compliance when compared with other populations. CPAP compliance is evaluated through the online treatment system Airview (Resmed), where compliance is defined as minimum 4 hours use for 70% of nights in the past 90 days.
Measured: 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 World Health Organization Well-being Index (WHO-5) questionnaire is performed at inclusion and 6 months after. The raw scores are transformed to a score between 0 and 100, where high scores indicate higher wellbeing. Scores for participants in CPAP treatment will be compared before and after treatment to examine the effect of CPAP on quality of life.
Measured: 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 functional outcome of sleep questionnaire (FOSQ-10) is performed at inclusion and 6 months after. A total score, with a potential value between 5-20, is calculated. Low values indicate excessive daytime sleepiness while high scores indicate no excessive daytime sleepiness. Scores for participants in CPAP treatment will be compared before and after treatment to examine the effect of CPAP on quality of life.
Measured: The questionnaire is answered at inclusion and 6 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Greenland
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Marit Eika Jørgensen, Md. Phd, Principal investigator, Steno Diabetes Center Greenland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264427
- Sponsor's protocol ID
- KVUG - 2022 - 10
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available for researcher who hold relevant approval from the Science Ethical Committee and health authorities.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland
- ClinicalTrials.gov ID
- NCT06264427
- Acronym / sponsor ID
- KVUG - 2022 - 10
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Morbid, Obstructive Sleep Apnea, MODY, Diabetic Retinopathy, Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Steno Diabetes Center GreenlandUniversity, hospital or other
- Collaborators
- Zealand University Hospital, University of Copenhagen
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Genetic: Whole genome sequencing, Diagnostic Test: VAGUS, Diagnostic Test: NightOwl, Device: CPAPAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes and/or morbid obesity (BMI >40)
- Over 18 years old
Key exclusion criteria (1 listed)
- Does not speak either English, Danish or Greenlandic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole genome sequencingScreening for MODY diabetes. Diabetic treatment will be adjusted based on the participant's diabetic genotype. | Genetic | Intervention arm |
| VAGUSTo 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 test | Intervention arm |
| NightOwlParticipants 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. | Diagnostic test | Intervention arm |
| CPAPParticipants 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). | Device | Intervention arm |
Primary outcome
Number of participants with MODY diabetes and their complication status
Time frame: Blood 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 complication
Time frame: Types 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 apnea
Time frame: 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.
What proportion of participants suffer from OSA.
3 secondary outcomes
CPAP compliance in Greenlandic patients
Time frame: 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).
Time frame: 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).
Time frame: The questionnaire is answered at inclusion and 6 months after.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Yes. IPD will be available for researcher who hold relevant approval from the Science Ethical Committee and health authorities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marit Eika Jørgensen, Md. Phd principal investigator
Steno Diabetes Center Greenland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole genome sequencing, VAGUS and NightOwl in people with Diabetes Mellitus, Type 2 and Obesity, Morbid, run by Steno Diabetes Center Greenland at 1 site in Greenland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greenland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mads Jensen, MD. (+299 34 46 23, MMSN@peqqik.gl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.