Status:
COMPLETED
The Role of Traditional or Western Diet in the TBC1D4 Gene on Glucose Homeostasis in Greenland Inuits
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Steno Diabetes Center Copenhagen
Novo Nordisk A/S
Conditions:
T2D
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Studies of Greenland Inuit before the 1980s found a low prevalence of type 2 diabetes (T2D) compared to Western populations. However, recent population studies in Greenland found a notably high preval...
Detailed Description
The overall objective of the study is to investigate whether a traditional marine diet high in fat and low in carbohydrate compared to a westernized diet could improve glycemic control in Greenland In...
Eligibility Criteria
Inclusion
- Participants who have provided written informed consent
- Age between 18 and 80 years
- Homozygous carriers of the nonsense p.Arg684Ter variant in the TBC1D4 gene (cases)
- Homozygous non-carriers of the nonsense p.Arg684Ter variant in the TBC1D4 gene (control)
Exclusion
- If study participants do not want to know whether they are carriers or non-carriers of the p.Arg684Ter variant in the TBC1D4 gene they will not be able to participate in the study
- BMI ≥ 18.5 kg/m2
- Diagnosis of diabetes (HbA1c ≥ 6,5% (48 mmol/mol)) or pharmacological treatment of diabetes (10).
- Use of peroral glucocorticoids
- Lack of compliance with the procedures in the study protocol, judged by Investigator
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2020
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04011904
Start Date
April 15 2019
End Date
November 23 2020
Last Update
November 25 2020
Active Locations (1)
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1
Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen
Copenhagen, Denmark