Bariatric Surgery CandidateADOS-2BNCT05140798
Abu Dhabi Diabetes and Obesity Study -2 Bariatric
An observational study of Bariatric Surgery Candidate, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery Candidate
- How many people
- 1,200 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 25 Apr 2016to 31 Dec 2022
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients attending ICLDC who are planning to undergo, or who have already undergone BS for treatment of severe obesity.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Alia Tikriti contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
Imperial College London Diabetes Centre
Abu Dhabi
Dr Nader Lessan, MD FRCP CCST
About this study
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.
Read the detailed description
Prior to participation, the nature of the study, the objectives of the study, the study procedures and any known or likely risks including specific information pertaining to the genetic testing technology will be explained to the subjects by the study team.
Written informed consent will be obtained after providing an information sheet with details regarding the study including the genetic analysis performed. The information sheet with consent form will be available in Arabic and English. The participant (or parent/guardian or legally authorised representative, as appropriate) must personally sign and date the latest approved version of the ICF before any study specific procedures are performed.
A copy of the signed ICF will be kept in the medical record, with the study data, and provided to the participant. The original signed ICF will be retained at the study site for 10 years after the end of the project and should be conveyed to ICLDC, to be stored electronically, for its records.
Each subject will be informed that their source medical records may be checked by representatives from the responsible authorities (ICLDC REC, ADHRTC, DOH) with applicable regulations. However, they will be made aware that all information will be treated with confidentiality.
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric Surgery, Resting Metabolic Rate, Monogenic Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
Measured: 3 months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
Measured: 6months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
Measured: 12months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
Measured: 18 months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
Measured: 24 months post BS
Change in weight
Body composition including weightloss will be measured SECA body composition analyser
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 36 months post BS
Secondary outcomes (30)
Change in liver fat
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver fat. They may decide whether or not to consent.
Measured: 3 months post BS
Change in liver fat
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver fat. They may decide whether or not to consent.
Measured: 6 months post BS
Change in liver fat
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver fat. They may decide whether or not to consent.
Measured: 12 months post BS
Change in liver fat
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver fat. They may decide whether or not to consent.
Measured: 18 months post BS
Change in liver fat
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver fat. They may decide whether or not to consent.
Measured: 24 months post BS
Change in liver fat
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver fat. They may decide whether or not to consent.
Measured: 36 months post BS
Change in liver thickness
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver thickness. They may decide whether or not to consent.
Measured: 3 months post BS
Change in liver thickness
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver thickness. They may decide whether or not to consent.
Measured: 6 months post BS
Change in liver thickness
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver thickness. They may decide whether or not to consent.
Measured: 12 months post BS
Change in liver thickness
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver thickness. They may decide whether or not to consent.
Measured: 18 months post BS
Change in liver thickness
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver thickness. They may decide whether or not to consent.
Measured: 24 months post BS
Change in liver thickness
If required, the subject may be asked to undergo an ultrasound elastography to analyse the liver thickness. They may decide whether or not to consent.
Measured: 36 months post BS
Change in serum leptin
serum leptin
Measured: 3 months post BS
Change in serum leptin
serum leptin
Measured: 6 months post BS
Change in serum leptin
serum leptin
Measured: 12 months post BS
Change in serum leptin
serum leptin
Measured: 18 months post BS
Change in serum leptin
serum leptin
Measured: 24 months post BS
Change in serum leptin
serum leptin
Measured: 36 months post BS
Change in insulin
insulin
Measured: 3 months post BS
Change in insulin
insulin
Measured: 6 months post BS
Change in insulin
insulin
Measured: 12 months post BS
Change in insulin
insulin
Measured: 18 months post BS
Change in insulin
insulin
Measured: 24 months post BS
Change in insulin
insulin
Measured: 36 months post BS
Change in serum cortisol
serum cortisol
Measured: 3 months post BS
Change in serum cortisol
serum cortisol
Measured: 6 months post BS
Change in serum cortisol
serum cortisol
Measured: 12 months post BS
Change in serum cortisol
serum cortisol
Measured: 18 months post BS
Change in serum cortisol
serum cortisol
Measured: 24 months post BS
Change in serum cortisol
serum cortisol
Measured: 36 months post BS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start25 Apr 2016
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Imperial College London Diabetes Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nader Lessan, MBBS MD FRCP CCST, Principal investigator, Imperial College London Diabetes Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140798
- Sponsor's protocol ID
- IREC026
- Acronym
- ADOS-2B
- Status last verified
- Nov 2021
- First submitted
- 5 Oct 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abu Dhabi Diabetes and Obesity Study -2 Bariatric
- ClinicalTrials.gov ID
- NCT05140798
- Acronym / sponsor ID
- ADOS-2B / IREC026
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric Surgery, Resting Metabolic Rate, Monogenic Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Imperial College London Diabetes CentreUniversity, hospital or other
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Dec 2021 (actual)
- 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.
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.
Detailed description
Prior to participation, the nature of the study, the objectives of the study, the study procedures and any known or likely risks including specific information pertaining to the genetic testing technology will be explained to the subjects by the study team.
Written informed consent will be obtained after providing an information sheet with details regarding the study including the genetic analysis performed. The information sheet with consent form will be available in Arabic and English. The participant (or parent/guardian or legally authorised representative, as appropriate) must personally sign and date the latest approved version of the ICF before any study specific procedures are performed.
A copy of the signed ICF will be kept in the medical record, with the study data, and provided to the participant. The original signed ICF will be retained at the study site for 10 years after the end of the project and should be conveyed to ICLDC, to be stored electronically, for its records.
Each subject will be informed that their source medical records may be checked by representatives from the responsible authorities (ICLDC REC, ADHRTC, DOH) with applicable regulations. However, they will be made aware that all information will be treated with confidentiality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patients attending ICLDC who are planning to undergo, or who have already undergone BS for treatment of severe obesity.
Key exclusion criteria (3 listed)
- 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.
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
Change in weight
Time frame: 3 months post BS
Body composition including weightloss will be measured SECA body composition analyser
Change in weight
Time frame: 6months post BS
Body composition including weightloss will be measured SECA body composition analyser
Change in weight
Time frame: 12months post BS
Body composition including weightloss will be measured SECA body composition analyser
Change in weight
Time frame: 18 months post BS
Body composition including weightloss will be measured SECA body composition analyser
Change in weight
Time frame: 24 months post BS
Body composition including weightloss will be measured SECA body composition analyser
Change in weight
Time frame: 36 months post BS
Body composition including weightloss will be measured SECA body composition analyser
Change in resting metabolic rate
Time frame: 3months post BS
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 .
Change in resting metabolic rate
Time frame: 6 months post BS
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 .
Change in resting metabolic rate
Time frame: 12 months post BS
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 .
Change in resting metabolic rate
Time frame: 18 months post BS
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 .
Change in resting metabolic rate
Time frame: 24 months post BS
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 .
Change in resting metabolic rate
Time frame: 36 months post BS
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 .
30 secondary outcomes
Change in liver fat
Time frame: 3 months post BS
Change in liver fat
Time frame: 6 months post BS
Change in liver fat
Time frame: 12 months post BS
Change in liver fat
Time frame: 18 months post BS
Change in liver fat
Time frame: 24 months post BS
Change in liver fat
Time frame: 36 months post BS
Change in liver thickness
Time frame: 3 months post BS
Change in liver thickness
Time frame: 6 months post BS
Change in liver thickness
Time frame: 12 months post BS
Change in liver thickness
Time frame: 18 months post BS
Change in liver thickness
Time frame: 24 months post BS
Change in liver thickness
Time frame: 36 months post BS
Change in serum leptin
Time frame: 3 months post BS
Change in serum leptin
Time frame: 6 months post BS
Change in serum leptin
Time frame: 12 months post BS
Change in serum leptin
Time frame: 18 months post BS
Change in serum leptin
Time frame: 24 months post BS
Change in serum leptin
Time frame: 36 months post BS
Change in insulin
Time frame: 3 months post BS
Change in insulin
Time frame: 6 months post BS
Change in insulin
Time frame: 12 months post BS
Change in insulin
Time frame: 18 months post BS
Change in insulin
Time frame: 24 months post BS
Change in insulin
Time frame: 36 months post BS
Change in serum cortisol
Time frame: 3 months post BS
Change in serum cortisol
Time frame: 6 months post BS
Change in serum cortisol
Time frame: 12 months post BS
Change in serum cortisol
Time frame: 18 months post BS
Change in serum cortisol
Time frame: 24 months post BS
Change in serum cortisol
Time frame: 36 months post BS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Alia Tikriti contact
Nader Lessan, MBBS MD FRCP CCST principal investigator
Imperial College London Diabetes Centre
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 Bariatric Surgery Candidate, 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 3 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: status not confirmed, as of the sponsor's last update on 1 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alia Tikriti (aaltikriti@icldc.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: 3 months post BS). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2021.