Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05140798
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-10-05
Brief Title:
Abu Dhabi Diabetes and Obesity Study -2 Bariatric
Sponsor:
Imperial College London Diabetes Centre
Organization:
Imperial College London Diabetes Centre
Study Overview
Official Title:
Abu Dhabi Diabetes and Obesity Study -2 Bariatric
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADOS-2B
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
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 parentguardian 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
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 parentguardian 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None