Prospective Study to Determine Long Term Impact of Bariatric Surgery

NCT02813707 | Unknown

• 1 other identifier: 16/008 2016 4272
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

Vitamins; Mineral; Surgery

Outcome Measures

Primary Outcomes (2)

• Postsurgical complications

  changes in body weight

  1 year

• Monitor the HbA1c levels

  Changes in the HbA1c Levels

  1 year

Secondary Outcomes (5)

• Status renal function

  1 year

• Monitor the Iron levels

  1year

• Monitor the PTH levels

  1year

• Monitor the thiamine level

  1 year

• Monitor the vitamins B12 levels

  1year

Interventions

QoL questionnaire regarding the long term complication OTHER

Micronutrients evaluation

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• United Arab Emirates University: lead

Study Sites (1)

Faculty of Medicine and Health Sciences UAE University

Al Ain City, AB, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Salah Gariballa, MD

  United Arab Emirates University

  STUDY CHAIR

Central Study Contacts

Prof. Juma AlKaabi, MD, PhD

CONTACT

+97137137472; j.kaabi@uaeu.ac.ae

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Consultant Endocrinologist

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: June 27, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: June 28, 2016

Record last verified: 2016-06

Locations

AE (1)