Abu Dhabi Diabetes and Obesity Study -2 Bariatric

Bariatric Surgery Candidate Clinical Trial

— ADOS-2B  

Official title:

Abu Dhabi Diabetes and Obesity Study -2 Bariatric

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140798
• Other study ID #: IREC026
• Status: Recruiting
• Start date: April 25, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Imperial College London Diabetes Centre
• Contact: Alia Tikriti
• Email: aaltikriti[@]icldc.ae
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients attending ICLDC who are planning to undergo, or who have already undergone BS for treatment of severe obesity.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity

Locations

Country	Name	City	State
United Arab Emirates	Imperial College London Diabetes Centre	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London Diabetes Centre

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Body composition including weightloss will be measured SECA body composition analyser	3 months post BS
Primary	Change in weight	Body composition including weightloss will be measured SECA body composition analyser	6months post BS
Primary	Change in weight	Body composition including weightloss will be measured SECA body composition analyser	12months post BS
Primary	Change in weight	Body composition including weightloss will be measured SECA body composition analyser	18 months post BS
Primary	Change in weight	Body composition including weightloss will be measured SECA body composition analyser	24 months post BS
Primary	Change in weight	Body composition including weightloss will be measured SECA body composition analyser	36 months post BS
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	3 months post BS
Secondary	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.	6 months post BS
Secondary	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.	12 months post BS
Secondary	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.	18 months post BS
Secondary	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.	24 months post BS
Secondary	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.	36 months post BS
Secondary	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.	3 months post BS
Secondary	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.	6 months post BS
Secondary	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.	12 months post BS
Secondary	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.	18 months post BS
Secondary	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.	24 months post BS
Secondary	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.	36 months post BS
Secondary	Change in serum leptin	serum leptin	3 months post BS
Secondary	Change in serum leptin	serum leptin	6 months post BS
Secondary	Change in serum leptin	serum leptin	12 months post BS
Secondary	Change in serum leptin	serum leptin	18 months post BS
Secondary	Change in serum leptin	serum leptin	24 months post BS
Secondary	Change in serum leptin	serum leptin	36 months post BS
Secondary	Change in insulin	insulin	3 months post BS
Secondary	Change in insulin	insulin	6 months post BS
Secondary	Change in insulin	insulin	12 months post BS
Secondary	Change in insulin	insulin	18 months post BS
Secondary	Change in insulin	insulin	24 months post BS
Secondary	Change in insulin	insulin	36 months post BS
Secondary	Change in serum cortisol	serum cortisol	3 months post BS
Secondary	Change in serum cortisol	serum cortisol	6 months post BS
Secondary	Change in serum cortisol	serum cortisol	12 months post BS
Secondary	Change in serum cortisol	serum cortisol	18 months post BS
Secondary	Change in serum cortisol	serum cortisol	24 months post BS
Secondary	Change in serum cortisol	serum cortisol	36 months post BS