ObesityNCT01843959
Abu Dhabi Diabetes and Obesity Study
An observational study of Obesity and Diabetes, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
Trial summary
A cross-sectional study investigating the aetiology, mechanisms and associated complications contributing to obesity and diabetes within the UAE population. The study will be carried out in two main sample populations; children and adults, and characterized by the occurrence of obesity and diabetes. Read more about this study
- Who is it for?
- Ages 5 to 80 yearsHealthy volunteers can take part
- How many people
- 2,130 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Mar 2013to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients from the Imperial College London Diabetes Centre, Abu Dhabi.
Who may be able to join
- All patients are eligible to participate in the study
Who cannot join
- Under 5 years of age
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Imperial College London Diabetes Centre
Abu Dhabi, 48338
About this study
Official title: Abu Dhabi Diabetes and Obesity Study (ADOS) - A Study on the Aetiology and Associated Risk Factors of Patients With Obesity/Diabetes Within the Emirati Population.
A cross-sectional study investigating the aetiology, mechanisms and associated complications contributing to obesity and diabetes within the UAE population. The study will be carried out in two main sample populations; children and adults, and characterized by the occurrence of obesity and diabetes. The main samples will then be divided into a subgroup for metabolomic analysis. Patients will be recruited from the Imperial College London Diabetes Centre. The study is aimed at elucidating the various factors that have an impact or may influence obesity and diabetes in the Emirati population.
Read the detailed description
Obesity and Type 2 diabetes (T2DM) have been regarded as global epidemics in developed countries and more recently in developing nations. Obesity (a T2DM risk factor) and T2DM present significant health risks as individual diseases and substantial risks in individuals with both complications (Deepa Nath, 2006). The UAE and USA have a similar prevalence of obesity, 36% and 35.7% respectively. Interestingly, the percentage of the population with T2DM between the two groups differs significantly, 25% and 8.7% respectively. The rate of T2DM in the Emirati population is 2.9 fold higher than in the US. This suggests an altered inter relationship between obesity and T2DM. One hypothesis that could explain such a variation is differences in body metabolism and central adiposity between the two populations. This will be assessed by measuring cardiometabolic risk factors, central adiposity and metabolomics. Analysis of the metabolomic profiles may help define the risk factors associated with diabetes and differences in metabolic activity between various ethnicities.
Another area of ample interest is the advanced glycation end-products (AGEs) metabolic pathways (Pietropaoli D, 2012). AGEs are formed at an increased rate in diabetes and have a number of detrimental effects such as retinopathy, nephropathy and atherosclerosis (Melpomeni Peppa, 2003). As such, determining the core mechanisms that result in metabolic and cardiovascular dysfunction will aid in identifying and developing therapeutic targets, which may in turn alleviate the deleterious effects of respective disorders such as diabetes.
The aetiology of diabetes is complex. However, adenovirus 36 has been shown to play a significant role in obesity and diabetes. As such, analysis of ADV-36 occurrence within the Emirati population may provide insight into a novel obesity and diabetes risk factor and could further clarify the relationship between obesity and T2DM.
This study may provide evidence that clarifies how obesity can result in T2DM, and why this occurrence is more predominant in the Emirati population. In addition, the assessment of AGEs within the population, ranging from people with diabetes and obesity to healthy individual, may provide insight into potential therapeutic targets, thereby improving overall heath in the population. Finally, the data may improve our knowledge of new risk factors such as ADV-36 and their subsequent effects on diabetes.
- Keywords
- adenovirus-36, Emirati population
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emirati Population | The individuals enrolled in this study will be divided into children (5-16 years of age) and adults (above 18). The groups will be further divided into BMI categories and glucose tolerance groups. * Group 1: Underweight (adjusted BMI <10th percentile) and no diabetes * Group 2: Normal weight (adjusted BMI 10th to 84.9th percentile) and no diabetes * Group 3: Overweight or obese children (adjusted BMI >= 85th percentile) and no diabetes * Group 4: Normal weight (adjusted BMI 10th to 84.9th percentile) and T1DM * Group 5: Overweight or obese children (adjusted BMI ≥ 85th percentile) and T1DM * Group 6: Normal weight (adjusted BMI 10th to 84.9th percentile) and T2DM * Group 7: Overweight or obese children (adjusted BMI ≥ 85th percentile) and T2DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the population in the U.A.E that are positive for adenovirus -36, specifically in children.
The initial aim of the study is to measure the prevalence of adenovirus 36 in the Emirati population.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London Diabetes Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nader Lessan, MD, Imperial College London Diabetes Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843959
- Sponsor's protocol ID
- IREC008
- Status last verified
- Oct 2021
- First submitted
- 25 Apr 2013
- Last updated
- 13 Oct 2021
- Results posted
- No
Publications
Almgren M, Atkinson R, He J, Hilding A, Hagman E, Wolk A, Thorell A, Marcus C, Naslund E, Ostenson CG, Schalling M, Lavebratt C. Adenovirus-36 is associated with obesity in children and adults in Sweden as determined by rapid ELISA. PLoS One. 2012;7(7):e41652. doi: 10.1371/journal.pone.0041652. Epub 2012 Jul 27.
PubMed 22848557Atkinson RL. Adenovirus-36 and obesity. Pediatr Obes. 2012 Apr;7(2):e18-9. doi: 10.1111/j.2047-6310.2011.00043.x. No abstract available.
PubMed 22434760
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abu Dhabi Diabetes and Obesity Study (ADOS) - A Study on the Aetiology and Associated Risk Factors of Patients With Obesity/Diabetes Within the Emirati Population.
- ClinicalTrials.gov ID
- NCT01843959
- Acronym / sponsor ID
- IREC008
- Keywords
- adenovirus-36, Emirati population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,130 participants (estimated)
- Lead sponsor
- Imperial College London Diabetes CentreUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross-sectional study investigating the aetiology, mechanisms and associated complications contributing to obesity and diabetes within the UAE population. The study will be carried out in two main sample populations; children and adults, and characterized by the occurrence of obesity and diabetes. The main samples will then be divided into a subgroup for metabolomic analysis. Patients will be recruited from the Imperial College London Diabetes Centre. The study is aimed at elucidating the various factors that have an impact or may influence obesity and diabetes in the Emirati population.
Detailed description
Obesity and Type 2 diabetes (T2DM) have been regarded as global epidemics in developed countries and more recently in developing nations. Obesity (a T2DM risk factor) and T2DM present significant health risks as individual diseases and substantial risks in individuals with both complications (Deepa Nath, 2006). The UAE and USA have a similar prevalence of obesity, 36% and 35.7% respectively. Interestingly, the percentage of the population with T2DM between the two groups differs significantly, 25% and 8.7% respectively. The rate of T2DM in the Emirati population is 2.9 fold higher than in the US. This suggests an altered inter relationship between obesity and T2DM. One hypothesis that could explain such a variation is differences in body metabolism and central adiposity between the two populations. This will be assessed by measuring cardiometabolic risk factors, central adiposity and metabolomics. Analysis of the metabolomic profiles may help define the risk factors associated with diabetes and differences in metabolic activity between various ethnicities.
Another area of ample interest is the advanced glycation end-products (AGEs) metabolic pathways (Pietropaoli D, 2012). AGEs are formed at an increased rate in diabetes and have a number of detrimental effects such as retinopathy, nephropathy and atherosclerosis (Melpomeni Peppa, 2003). As such, determining the core mechanisms that result in metabolic and cardiovascular dysfunction will aid in identifying and developing therapeutic targets, which may in turn alleviate the deleterious effects of respective disorders such as diabetes.
The aetiology of diabetes is complex. However, adenovirus 36 has been shown to play a significant role in obesity and diabetes. As such, analysis of ADV-36 occurrence within the Emirati population may provide insight into a novel obesity and diabetes risk factor and could further clarify the relationship between obesity and T2DM.
This study may provide evidence that clarifies how obesity can result in T2DM, and why this occurrence is more predominant in the Emirati population. In addition, the assessment of AGEs within the population, ranging from people with diabetes and obesity to healthy individual, may provide insight into potential therapeutic targets, thereby improving overall heath in the population. Finally, the data may improve our knowledge of new risk factors such as ADV-36 and their subsequent effects on diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emirati Population | – | –The individuals enrolled in this study will be divided into children (5-16 years of age) and adults (above 18). The groups will be further divided into BMI categories and glucose tolerance groups. * Group 1: Underweight (adjusted BMI <10th percentile) and no diabetes * Group 2: Normal weight (adjusted BMI 10th to 84.9th percentile) and no diabetes * Group 3: Overweight or obese children (adjusted BMI >= 85th percentile) and no diabetes * Group 4: Normal weight (adjusted BMI 10th to 84.9th percentile) and T1DM * Group 5: Overweight or obese children (adjusted BMI ≥ 85th percentile) and T1DM * Group 6: Normal weight (adjusted BMI 10th to 84.9th percentile) and T2DM * Group 7: Overweight or obese children (adjusted BMI ≥ 85th percentile) and T2DM |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from the Imperial College London Diabetes Centre, Abu Dhabi.
Key inclusion criteria (1 listed)
- All patients are eligible to participate in the study
Key exclusion criteria (1 listed)
- Under 5 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of the population in the U.A.E that are positive for adenovirus -36, specifically in children.
Time frame: One year
The initial aim of the study is to measure the prevalence of adenovirus 36 in the Emirati population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Background: PubMed 22848557Almgren M, Atkinson R, He J, Hilding A, Hagman E, Wolk A, Thorell A, Marcus C, Naslund E, Ostenson CG, Schalling M, Lavebratt C. Adenovirus-36 is associated with obesity in children and adults in Sweden as determined by rapid ELISA. PLoS One. 2012;7(7):e41652. doi: 10.1371/journal.pone.0041652. Epub 2012 Jul 27.
- Background: PubMed 22434760Atkinson RL. Adenovirus-36 and obesity. Pediatr Obes. 2012 Apr;7(2):e18-9. doi: 10.1111/j.2047-6310.2011.00043.x. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the population in the U.A.E that are positive for adenovirus -36, specifically in children. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843959, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.