Abu Dhabi Diabetes and Obesity Study -2 Bariatric (ADOS-2B)

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Alia Tikriti; Email: aaltikriti@icldc.ae

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Recruiting
    • Imperial College London Diabetes Centre
    • Contact: Dr Nader Lessan, MD FRCP CCST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
Change in serum leptin	serum leptin	3 months post BS
Change in serum leptin	serum leptin	6 months post BS
Change in serum leptin	serum leptin	12 months post BS
Change in serum leptin	serum leptin	18 months post BS
Change in serum leptin	serum leptin	24 months post BS
Change in serum leptin	serum leptin	36 months post BS
Change in insulin	insulin	3 months post BS
Change in insulin	insulin	6 months post BS
Change in insulin	insulin	12 months post BS
Change in insulin	insulin	18 months post BS
Change in insulin	insulin	24 months post BS
Change in insulin	insulin	36 months post BS
Change in serum cortisol	serum cortisol	3 months post BS
Change in serum cortisol	serum cortisol	6 months post BS
Change in serum cortisol	serum cortisol	12 months post BS
Change in serum cortisol	serum cortisol	18 months post BS
Change in serum cortisol	serum cortisol	24 months post BS
Change in serum cortisol	serum cortisol	36 months post BS

Collaborators and Investigators

• Sponsor: Imperial College London Diabetes Centre
• Investigators: Principal Investigator: Nader Lessan, MBBS MD FRCP CCST, Imperial College London Diabetes Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Bariatric Surgery; Resting Metabolic Rate; Monogenic Obesity
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: IREC026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No