Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05140798
Other study ID # IREC026
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03809182 - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. Phase 4
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Withdrawn NCT05845359 - Intraoperative Methadone for Postoperative Pain Control Phase 4
Not yet recruiting NCT04343040 - Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients N/A
Withdrawn NCT03095404 - Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery Early Phase 1
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT04883268 - Focusing on Body Functionality After Bariatric Surgery N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT02300168 - Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery N/A
Unknown status NCT01264120 - The Impact of a Bariatric Rehabilitation Service on Patient Outcomes N/A
Recruiting NCT03972319 - Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study Early Phase 1
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Completed NCT04219852 - Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Recruiting NCT05570474 - Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery N/A