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Prospective Study to Determine Long Term Impact of Bariatric Surgery (BS-PART2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813707
Recruitment Status : Unknown
Verified June 2016 by Juma Alkaabi, United Arab Emirates University.
Recruitment status was:  Recruiting
First Posted : June 27, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Juma Alkaabi, United Arab Emirates University

Brief Summary:
The World Health Organization (WHO) statistics, in 2008, there were more than 1.4 billion adults, aged 20 and older, and were overweight. Of these over 200 million men and nearly 300 million women are obese. Body Mass Index (BMI) more than 30 is considered as obese and increasingly bariatric surgery is the commonest way used nowadays to lose weight. Moreover, surgery will influence many other health factors and parameters. Many studies prove the improvement of metabolic and psychological status of patients post bariatric surgery. In addition, many vitamins will be affected and should be replaced. This research study is continuation (PART 2) of previously approved study (approval: 13/54). Brief findings of the study are attached. Our aim in this part of the study to assess long term the impact of bariatric surgery on metabolic, nutritional and quality of life status on patients post bariatric procedure of at least 12 months post-surgery follow up. As we noted in our previous initial study that there is significant loss the collection of the data due to "no show" for proper follow up routine care. Previously it was approved to consent patients by phone calls and extract information regarding Quality of Life (QoL) post-surgery. This will be replaced by seeing the patients in the outpatient clinic and providing the necessary information and consent.

Condition or disease Intervention/treatment
Quality of Life Other: QoL questionnaire regarding the long term complication

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Prospective Study to Determine Long Term Impact of Bariatric Surgery on Metabolic, Nutritional and Quality of Life Status: PART 2
Study Start Date : April 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: QoL questionnaire regarding the long term complication
    Micronutrients evaluation


Primary Outcome Measures :
  1. Postsurgical complications [ Time Frame: 1 year ]
    changes in body weight

  2. Monitor the HbA1c levels [ Time Frame: 1 year ]
    Changes in the HbA1c Levels


Secondary Outcome Measures :
  1. Status renal function [ Time Frame: 1 year ]
    occurrence of renal stone

  2. Monitor the Iron levels [ Time Frame: 1year ]
    Changes in Iron level

  3. Monitor the PTH levels [ Time Frame: 1year ]
    changes in the levels of PTH

  4. Monitor the thiamine level [ Time Frame: 1 year ]
    change in level of thiamine

  5. Monitor the vitamins B12 levels [ Time Frame: 1year ]
    changes in Vitamin B12 levels



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will be identified from the list of the bariatric surgery done at Tawam hospital.

The study will be conducted in Tawam Hospital where patients come for their routine bariatric surgery. A written informed consent will be taken from all the patients willing to participate in the study. Patients would be informed about the objectives / goals of the study.

Criteria

Inclusion Criteria:

  • All adult patients who underwent any type of bariatric surgery at Tawam Hospital with at least 12 months duration post-operative

Exclusion Criteria:

  • Not willing to participate in the study.
  • No show

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813707


Contacts
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Contact: Prof. Juma AlKaabi, MD, PhD +97137137472 ext 472 j.kaabi@uaeu.ac.ae

Locations
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United Arab Emirates
Faculty of Medicine and Health Sciences UAE University Recruiting
Al Ain, AB, United Arab Emirates
Contact: Juma M Alkaabi, MD    +97137137472 ext 472    j.kaabi@uaeu.ac.ae   
Sponsors and Collaborators
United Arab Emirates University
Investigators
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Study Chair: Salah Gariballa, MD United Arab Emirates University
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Responsible Party: Juma Alkaabi, Professor of Medicine, Consultant Endocrinologist, United Arab Emirates University
ClinicalTrials.gov Identifier: NCT02813707    
Other Study ID Numbers: 16/008 2016 4272
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Keywords provided by Juma Alkaabi, United Arab Emirates University:
Vitamins
Mineral
Surgery