Abu Dhabi Diabetes and Obesity Study -2 Bariatric
ADOS-2B
1 other identifier
observational
1,200
1 country
1
Brief Summary
Study on outcomes on bariatric surgery, particularly in terms of metabolic parameters in the UAE is scant. Also Genetic data from this population is limited and hence a study on genetic determinants of response to bariatric surgery is highly warranted. This study is expected to provide a better understanding of the causes of severe obesity in the UAE population and help us to evaluate the efficacy of Bariatric surgery in patients with genetic forms of obesity. The information generated will allow us to better advise patients regarding the risks and benefits of Bariatric Surgery as a treatment. Objective To investigate the metabolic outcomes of bariatric surgery, to study the prevalence of monogenic forms of obesity among a cohort of patients with morbid obesity who underwent bariatric surgery and to compare the outcomes of Bariatric surgery in patients with and without underlying genetic condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
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
April 25, 2016
CompletedFirst Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedDecember 1, 2021
November 1, 2021
6.7 years
October 5, 2021
November 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
3 months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
6months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
12months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
18 months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
24 months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
36 months post BS
Change in resting metabolic rate
Our body uses energy while at rest, which we will be measuring it using an indirect calorimeter. The subject should ideally be fasting for at least 8 hrs before the procedure. If they are eligible, then they will asked to lie down on a couch with their upper body covered with a transparent hood, they will relax and breathe normally during the procedure .
3months post BS
Change in resting metabolic rate
Our body uses energy while at rest, which we will be measuring it using an indirect calorimeter. The subject should ideally be fasting for at least 8 hrs before the procedure. If they are eligible, then they will asked to lie down on a couch with their upper body covered with a transparent hood, they will relax and breathe normally during the procedure .
6 months post BS
Change in resting metabolic rate
Our body uses energy while at rest, which we will be measuring it using an indirect calorimeter. The subject should ideally be fasting for at least 8 hrs before the procedure. If they are eligible, then they will asked to lie down on a couch with their upper body covered with a transparent hood, they will relax and breathe normally during the procedure .
12 months post BS
Change in resting metabolic rate
Our body uses energy while at rest, which we will be measuring it using an indirect calorimeter. The subject should ideally be fasting for at least 8 hrs before the procedure. If they are eligible, then they will asked to lie down on a couch with their upper body covered with a transparent hood, they will relax and breathe normally during the procedure .
18 months post BS
Change in resting metabolic rate
Our body uses energy while at rest, which we will be measuring it using an indirect calorimeter. The subject should ideally be fasting for at least 8 hrs before the procedure. If they are eligible, then they will asked to lie down on a couch with their upper body covered with a transparent hood, they will relax and breathe normally during the procedure .
24 months post BS
Change in resting metabolic rate
Our body uses energy while at rest, which we will be measuring it using an indirect calorimeter. The subject should ideally be fasting for at least 8 hrs before the procedure. If they are eligible, then they will asked to lie down on a couch with their upper body covered with a transparent hood, they will relax and breathe normally during the procedure .
36 months post BS
Secondary Outcomes (30)
Change in liver fat
3 months post BS
Change in liver fat
6 months post BS
Change in liver fat
12 months post BS
Change in liver fat
18 months post BS
Change in liver fat
24 months post BS
- +25 more secondary outcomes
Eligibility Criteria
The study population will be patients attending ICLDC with severe obesity, who have previously had, or are considering metabolic surgery and also control group of patients who are not considering bariatric surgery.
You may qualify if:
- Patients attending ICLDC who are planning to undergo, or who have already undergone BS for treatment of severe obesity.
You may not qualify if:
- Any malignant or chronic inflammatory disease,
- Children in the absence of parental consent
- Anyone who is not able to take part for reasons of significant incapacity or disability, including mental disability, preventing discussion of clinical history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London Diabetes Centre
Abu Dhabi, United Arab Emirates
Study Officials
- PRINCIPAL INVESTIGATOR
Nader Lessan, MBBS MD FRCP CCST
Imperial College London Diabetes Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2021
First Posted
December 1, 2021
Study Start
April 25, 2016
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
December 1, 2021
Record last verified: 2021-11