Clinical trial NCT05140798: Abu Dhabi Diabetes and Obesity Study -2 Bariatric
Official title: Abu Dhabi Diabetes and Obesity Study -2 Bariatric
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric Surgery
Resting Metabolic Rate
Monogenic Obesity
Lead sponsor: Imperial College London Diabetes Centre
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in weight
timeFrame: 3 months post BS
measure: Change in weight
timeFrame: 6months post BS
measure: Change in weight
timeFrame: 12months post BS
measure: Change in weight
timeFrame: 18 months post BS
measure: Change in weight
timeFrame: 24 months post BS
measure: Change in weight
timeFrame: 36 months post BS
measure: Change in resting metabolic rate
timeFrame: 3months post BS
measure: Change in resting metabolic rate
timeFrame: 6 months post BS
measure: Change in resting metabolic rate
timeFrame: 12 months post BS
measure: Change in resting metabolic rate
timeFrame: 18 months post BS
measure: Change in resting metabolic rate
timeFrame: 24 months post BS
measure: Change in resting metabolic rate
timeFrame: 36 months post BS
Secondary outcomes:
measure: Change in liver fat
timeFrame: 3 months post BS
measure: Change in liver fat
timeFrame: 6 months post BS
measure: Change in liver fat
timeFrame: 12 months post BS
measure: Change in liver fat
timeFrame: 18 months post BS
measure: Change in liver fat
timeFrame: 24 months post BS
measure: Change in liver fat
timeFrame: 36 months post BS
measure: Change in liver thickness
timeFrame: 3 months post BS
measure: Change in liver thickness
timeFrame: 6 months post BS
measure: Change in liver thickness
timeFrame: 12 months post BS
measure: Change in liver thickness
timeFrame: 18 months post BS
measure: Change in liver thickness
timeFrame: 24 months post BS
measure: Change in liver thickness
timeFrame: 36 months post BS
measure: Change in serum leptin
timeFrame: 3 months post BS
measure: Change in serum leptin
timeFrame: 6 months post BS
measure: Change in serum leptin
timeFrame: 12 months post BS
measure: Change in serum leptin
timeFrame: 18 months post BS
measure: Change in serum leptin
timeFrame: 24 months post BS
measure: Change in serum leptin
timeFrame: 36 months post BS
measure: Change in insulin
timeFrame: 3 months post BS
measure: Change in insulin
timeFrame: 6 months post BS
measure: Change in insulin
timeFrame: 12 months post BS
measure: Change in insulin
timeFrame: 18 months post BS
measure: Change in insulin
timeFrame: 24 months post BS
measure: Change in insulin
timeFrame: 36 months post BS
measure: Change in serum cortisol
timeFrame: 3 months post BS
measure: Change in serum cortisol
timeFrame: 6 months post BS
measure: Change in serum cortisol
timeFrame: 12 months post BS
measure: Change in serum cortisol
timeFrame: 18 months post BS
measure: Change in serum cortisol
timeFrame: 24 months post BS
measure: Change in serum cortisol
timeFrame: 36 months post BS
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
Study officials:
affiliation: Imperial College London Diabetes Centre
name: Nader Lessan, MBBS MD FRCP CCST
role: PRINCIPAL_INVESTIGATOR
References: