NCT04270097

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

6.7 years

First QC Date

May 21, 2019

Last Update Submit

February 12, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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).

    2020-2021

Study Arms (1)

Emirati Genetic T2D cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emirati patients attending Imperial College London Diabetes Centre for general health screening or for a 3-month follow-up checkup.

You may qualify if:

  • 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

You may not qualify if:

  • Other types of diabetes
  • Undergone a recent surgical operation that hinders them from carrying out their normal day to day chores

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London Diabetes Centre

Abu Dhabi, 48338, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Nader Lessan

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

February 17, 2020

Study Start

March 23, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations