NCT05140798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2016

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

6.7 years

First QC Date

October 5, 2021

Last Update Submit

November 21, 2021

Conditions

Keywords

Bariatric SurgeryResting Metabolic RateMonogenic Obesity

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (30)

  • Change in liver fat

    3 months post BS

  • Change in liver fat

    6 months post BS

  • Change in liver fat

    12 months post BS

  • Change in liver fat

    18 months post BS

  • Change in liver fat

    24 months post BS

  • +25 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London Diabetes Centre

Abu Dhabi, United Arab Emirates

RECRUITING

Study Officials

  • Nader Lessan, MBBS MD FRCP CCST

    Imperial College London Diabetes Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alia Tikriti

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2021

First Posted

December 1, 2021

Study Start

April 25, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

December 1, 2021

Record last verified: 2021-11

Locations