Obesity Clinical Trial
Official title:
Genetic and Epigenetic Contribution to Increased Risk of T2D in the UAE
NCT number | NCT04270097 |
Other study ID # | IREC 025 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 23, 2016 |
Est. completion date | December 1, 2022 |
T2D is a global public health crisis and a threat to socioeconomic development of all
nations, particularly in developing countries. Countries in the Gulf region, including the
UAE, have some of the highest rates of T2D worldwide. The epidemic in the region has grown in
parallel with the worldwide rise in obesity, which is fuelled by rapid urbanization,
nutrition transition, and increasing sedentary lifestyles. Whether these unfavourable changes
in environmental risk factors can explain the increased risk of T2D in the region, or whether
the populations in the Gulf region are more genetically susceptible to disease is yet to be
investigated.
In this study, for the first time, the contribution of environmental, genetic, and epigenetic
factors towards the increased risk of T2D amongst the population of the UAE will be
investigated. This will be through, firstly, identifying environmental risk factors with
higher prevalence rates, and bigger effect sizes on T2D in the UAE in comparison to Europe.
Secondly, identifying genetic variants known to predict T2D in Europeans/other populations,
but with stronger association with T2D in Emiratis. Thirdly, identifying novel genetic
variants that are perhaps rare in Europeans/other populations, but confer increased risk for
T2D in the UAE. Lastly, candidate genes underlying T2D pathogenesis via epigenetic mechanisms
will be identified in Emiratis and Europeans. The end result is to identify the underlying
candidate markers and mechanisms involved in T2D pathogenesis, which can better explain
differences in magnitude of risk across populations.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Fasted for at least 8 hrs - Arab-Emiati ethnicity - Males and Females - Diagnosed with prediabetes OR - Diagnosed with type 2 diabetes OR - Have normal glucose tolerance Exclusion Criteria: - Other types of diabetes - Undergone a recent surgical operation that hinders them from carrying out their normal day to day chores |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | Imperial College London Diabetes Centre | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
Imperial College London Diabetes Centre |
United Arab Emirates,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical activity levels at work, transport and leisure time in a typical day among Emiratis with or without T2D. | Reported physical activity in a typical week collected using the Global Physical Activity Questionnaire (GPAQ).The GPAQ comprises of 16 items that quantify the physical activity levels of a normal week for an individual. It was developed to estimate the total weekly volume of moderate-to-vigorous physical activity (MVPA) in a typical week among three domains; work, transportation, and recreational/leisure activities. Based on the GPAQ guidelines, calculated total activity score is classified into three categories, overall low- (LPA), moderate- (MPA), or high- (HPA) physical activity. | 2017-2019 | |
Primary | Total physical activity levels through 7 days among Emiratis with or without T2D. | Physical activity levels during a week including 5 working days and 2 weekend days collected using Actigraph GT9X accelerometer. Minutes per day of moderate to vigorous physical activity (MVPA) based on accelerometry calculated in ActiLife software. | 2018-2020 | |
Primary | Association of low physical activity (LPA) with risk of T2D in Emiratis | Association between LPA and T2D statistically determined with logistic regression analysis by odds ratio (OR). The OR of having LPA and T2D versus having MPA or HPA and T2D. | 2018-2020 | |
Primary | Association of obesity with risk of T2D among Emiratis | Body mass index (BMI) calculated as weight in kilograms divided by the square of height in meters (Kg/m2), and classified as normal ( < 24kg/m2), overweight (25 - 29kg/m2), and obese ( = 30kg/m2). Association between BMI and T2D statistically determined with logistic regression analysis by odds ratio (OR). OR will define the increased risk of T2D with a unit increase in BMI (1kg/m2). |
2017-2019 | |
Primary | Genetic risk variants associated with increased risk of T2D in Emiratis | Global screening array will be used to genotype >500,000 Single Nucleotide Polymorphisms (SNPs) from DNA samples extracted from whole blood samples , which are collected at the inclusion visit from participants with or without T2D. Association between evaluated genetic variants (SNPs) and T2D statistically determined if the p-value is found to be close to or lower than the Genome-wide significance threshold (p <5*10-8). |
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