T2D Clinical Trial
Official title:
The Role of Traditional or Western Diet in the TBC1D4 Gene on Glucose
Verified date | November 2020 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 prevalence of diabetes (9%) and pre-diabetes (19%) in the adult population. In many studies worldwide an increase in obesity, diabetes, and cardiovascular disease has been ascribed to social transition and in particular urbanization, but the Inuit in Greenland do not fit the pattern. Paradoxically, the highest prevalence of diabetes is seen in the least urbanized areas. Thus, while previously rare, T2D has become epidemic in Inuit. In a recent study by Moltke et al found that a variant in the TBC1D4 gene was strongly associated with insulin resistance in skeletal muscle, high postprandial blood glucose and a high risk of T2D. The rapid increase in the prevalence of T2D and other metabolic traits and the well documented genetic susceptibility indicates that lifestyle components, particularly physical activity, and diet significantly modify the genetic effects on glucose homeostasis. Thus, changing dietary habits from a diet high in traditional foods, mostly consisting of marine mammals and fish (high in protein and unsaturated fats, and low in carbohydrate) to a westernized diet, with high contents of sugar and saturated fat may have increased the T2D incidence in Arctic Inuit. The investigators will perform a 4-week cross-over intervention study of the traditional diet versus a western diet among homozygous carriers and WTs on 2-hour glucose after an oral glucose tolerance test (OGTT). In addition, the investigators will examine the effects on cardiometabolic abnormalities such as low-grade systemic inflammation and dyslipidemia. Furthermore, the investigators will characterize the metabolic phenotype of participants, as well as gut microbiota and brown adipose tissue markers to elucidate the molecular mechanisms underlying potential improvements of a traditional Inuit diet.
Status | Completed |
Enrollment | 64 |
Est. completion date | November 23, 2020 |
Est. primary completion date | November 23, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Novo Nordisk A/S, Steno Diabetes Center Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in 2-h post-OGTT glucose in blood between the baseline and endpoint change in the two periods | 2 hour post oral glucose tolerance test glucose mesurement in blood (mmol/L) | Week 1, Week 4 and week 8 | |
Secondary | Changes in Hba1c between the baseline and endpoint change in the two periods | fasting measurement of blood glycated hemoglobin (%) | Week 1, Week 4 and week 8 | |
Secondary | Changes in fasting blood glucose between the baseline and endpoint change in the two periods | Fasting measurement of blood glucose (mmol/L) | Week 1, Week 4 and week 8 | |
Secondary | Changes in 30 min post OGTT between the baseline and endpoint change in the two periods | Measurement of blood glucose 30 min after OGTT (mmol/L) | Week 1, Week 4 and week 8 | |
Secondary | Continuous glucose monitoring | Continuous glucose monitor from Abbott is worn for 14 days in each period providing glucose measurements continuously (mmol/L). | Week 2 and Week 6 | |
Secondary | Insulin sensitivity and secretion | Measured as part of the OGTT. Plasma glucose (mmol/l). Plasma insulin - fasting (pmol/l) | Week 1, Week 4 and week 8 | |
Secondary | Changes in blood lipids between the baseline and endpoint change in the two periods | Measurements of total and HDL cholesterol (mmol/L) and triglycerides (mmol/L). | Week 1, Week 4 and week 8 | |
Secondary | Changes in gastrointestinal hormones between the baseline and endpoint change in the two periods | Measurements of e.g. GLP-1, PYY and GIP (pmol/L) in blood. | Week 1, Week 4 and week 8 | |
Secondary | Changes in gut microbiota composition between the baseline and endpoint change in the two periods | Measured on fecal samples | Week 1, Week 4 and week 8 | |
Secondary | Changes in C-Reactive Protein between the baseline and endpoint change in the two periods | Blood measurements of C-Reactive Protein (mg/L) | Week 1, Week 4 and week 8 | |
Secondary | Changes in Interleukin-6 between the baseline and endpoint change in the two periods | Blood measurements of Interleukin-6 (pg/mL) | Week 1, Week 4 and week 8 | |
Secondary | Changes in small metabolites between the baseline and endpoint change in the two periods | Measured using blood metabolomic measurements of amino acids, lipids, and other small metabolites (umol/L) | Week 1, Week 4 and week 8 | |
Secondary | Changes in weight between the baseline and endpoint change in the two periods | Measured using a Tanita body composition analyser. Body weight in kilograms | Week 1, Week 4 and week 8 | |
Secondary | Changes in body composition between the baseline and endpoint change in the two periods | Measured using a Tanita body composition analyser. Fat free mass and Body fat mass in kilograms used to calculate body fat percentage. | Week 1, Week 4 and week 8 | |
Secondary | Changes in waist and hip circumference between the baseline and endpoint change in the two periods | Measured using measurement tape | Week 1, Week 4 and week 8 | |
Secondary | Changes in fatty acids (compliance measurement) between the baseline and endpoint change in the two periods | Objective measures of compliance with fish intake, fatty acids (%FA) in blood. | Week 1, Week 4 and week 8 | |
Secondary | Changes in alkylresorcinols (compliance measurement) between the baseline and endpoint change in the two periods | Objective measures of compliance with grain intake, alkylresorcinols (umol/L) in blood. | Week 1, Week 4 and week 8 | |
Secondary | Changes in blood pressure (BP) between the baseline and endpoint change in the two periods | Systolic BP (mmHG) Diastolic BP (mmHG) | Week 1, Week 4 and week 8 |
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