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The Role of Traditional or Western Diet in the TBC1D4 Gene on Glucose Homeostasis in Greenland Inuits

NCT04011904 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-11-25

No results posted yet for this study

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 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.

Conditions

Interventions

OTHER

Cross-over study

Traditional Inuit Diet vs Westernized Diet

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2020-11-23
Completion
2020-11-23

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011904 on ClinicalTrials.gov