Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-28 @ 4:39 PM
Study NCT ID:
NCT01843959
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2013-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abu Dhabi Diabetes and Obesity Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2013-04-30', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of the population in the U.A.E that are positive for adenovirus -36, specifically in children.', 'timeFrame': 'One year', 'description': 'The initial aim of the study is to measure the prevalence of adenovirus 36 in the Emirati population.'}]}, 'conditionsModule': {'keywords': ['adenovirus-36', 'Emirati population'], 'conditions': ['Obesity', 'Diabetes']}, 'referencesModule': {'references': [{'pmid': '22848557', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22434760', 'type': 'BACKGROUND', 'citation': 'Atkinson 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAnother 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the Imperial College London Diabetes Centre, Abu Dhabi.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients are eligible to participate in the study\n\nExclusion Criteria:\n\n* Under 5 years of age'}, 'identificationModule': {'nctId': 'NCT01843959', 'briefTitle': 'Abu Dhabi Diabetes and Obesity Study', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London Diabetes Centre'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'IREC008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emirati Population', 'description': '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.\n\n\\* Group 1: Underweight (adjusted BMI \\<10th percentile) and no diabetes\n\n* Group 2:\n\nNormal weight (adjusted BMI 10th to 84.9th percentile) and no diabetes\n\n* Group 3:\n\nOverweight or obese children (adjusted BMI \\>= 85th percentile) and no diabetes\n\n* Group 4:\n\nNormal weight (adjusted BMI 10th to 84.9th percentile) and T1DM\n\n* Group 5:\n\nOverweight or obese children (adjusted BMI ≥ 85th percentile) and T1DM\n\n* Group 6:\n\nNormal weight (adjusted BMI 10th to 84.9th percentile) and T2DM\n\n* Group 7:\n\nOverweight or obese children (adjusted BMI ≥ 85th percentile) and T2DM'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48338', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'Imperial College London Diabetes Centre', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London Diabetes Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Endocrinologist', 'investigatorFullName': 'Dr Nader Lessan, MD', 'investigatorAffiliation': 'Imperial College London Diabetes Centre'}}}}