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Quality of LifeBS-PART2NCT02813707

Prospective Study to Determine Long Term Impact of Bariatric Surgery

An observational study of Quality of Life, run by United Arab Emirates University at 1 site in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Quality of Life
What is being tested?
QoL questionnaire regarding the long term complication
How many people
150 participants
Where
1 siteUnited Arab Emirates
Study dates
Apr 2016to Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Prof. Juma AlKaabi, MD, PhD contact

+97137137472 ext. 472

j.kaabi@uaeu.ac.ae

United Arab Emirates1 site, 1 recruiting
  • Faculty of Medicine and Health Sciences UAE University

    Al Ain City, AB

    Juma M Alkaabi, MD, +97137137472 ext. 472, j.kaabi@uaeu.ac.ae

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: A Prospective Study to Determine Long Term Impact of Bariatric Surgery on Metabolic, Nutritional and Quality of Life Status: PART 2

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.

Read the detailed description

There is no data available in the UAE regarding the impact of bariatric surgery on metabolic, nutritional and psychological status of the patient. Therefore, studying that will help the community in establishing a database specific for the country instead of relying on other countries statistics and data.

In 2009, figures from WHO have revealed that 39.9% of women in United Arab Emirates (UAE) are obese which considered the 7th highest proportion in the world. On the other hand, 25.6% of men are obese in UAE which considered the 9th highest proportion in the world.

The search for ideal weight loss operation started more than 50 years ago. First bariatric surgery performed in 1954 by Kremen and his associates which involved the anastomosis of upper and lower intestine that bypasses large amount of absorptive circuit. Mason, Ito et al. developed the Gastric Bypass in 1967, which led to fewer complications than the intestinal bypass. A later improvement, the Roux-en-Y Gastric Bypass, proved technically difficult to perform but led to long-term sustained weight loss, no protein-calorie malabsorption and little vitamin or mineral deficiencies. Many studies and researches are conducting studying the impact of bariatric surgery on different health parameters.

There are many studies regarding the effect of bariatric surgery on diabetic and metabolic parameters. Study of 15 patients with Body Mass Index (BMI) between 30-35 kg/m2 with type II diabetes underwent Roux-En-Y gastric bypass with 1 year follow up. Results that diabetes mellitus remission achieved in 93% of cases with significant drop in blood glucose and HbA1C (p≤ 0.05 \& p ≤ 0.001) respectively. Another study, 17 obese patients with type II diabetes mellitus (DM) received the duodenal-jejunal bypass liner followed for 24 weeks. HbA1C improved from 8.4±0.2 to 7.0±0.2% (p≤0.01). A third study regarding the effect of laparoscopic Roux-En-Y gastric bypass (LRYGBP) on (Diabetes mellitus II) DMII for period of 5 years. 1160 patients underwent LRYGBP and 240 (21%) has impaired fasting glucose (IFG) or DMII. Body mass index (BMI) decreased from 50.1 to 34 kg/m2. Hemoglobin A1C (HbA1C) returned to normal levels (83%) or markedly improved (17%) in all patients. Reduction in use of oral anti-DM (80%) and insulin (79%) followed surgical treatment. Furthermore, in other study 52 morbidly obese patients were studied after sleeve gastrectomy. HbA1C changed form 6.0 ± 1.3% to 5.4 ± 0.8% to 5.4 ± 0.8% at 6 and 12 months respectively. Triglyceride decreased from 159± 87 to 116± 41 and 116± 62 mg/dl, while High density lipoprotein (HDL) increased from 46± 12 to 50 ±12 and 56±13 mg/dl at 6 and 12 months. There is a study of 100 obese patients after laparoscopic adjustable gastric banding and the influence on body mass index (BMI), insulin concentration and lipid profile. Results include significant decrease in BMI, normalization of metabolic parameters, with improvement of type II DM, Hypertension (HTN), and sleep apnea.

There is a study about improving renal function 12 months after bariatric surgery. They studied changes in Glomerular Filtration Rate (GFR) before and 1 year after the surgery in 223 severely obese patients. Normal GFR was 90-125 ml/min. They found that GFR increased in patients with previously normal, Chronic kidney disease (CKD) stage II and CKD stage III. Another 12- month prospective study, regarding the effect of bariatric surgery on renal function and systemic inflammation and blood pressure. A total of 34 morbidly obese patients were investigated at baseline, 1 month and 12 months after Roux-En-Y gastric bypass. The results showed a significant decrease in body mass index (BMI), mean arterial pressure, and urinary and serum inflammatory markers (all p≤0.001). There are many studies in the literature regarding improving quality of life (QoL) after bariatric surgery. There was a study in which obese patient's QoL was investigated early and medium-term changes following Roux-en-y gastric bypass.

There was a study regarding the sexual function post bariatric surgery. In a prospective study of 39 men underwent bariatric surgery. Their sexual function was assessed by mean of international index of erectile function (IIEF) before and 1 year after the surgery. In addition to, metabolic and hormonal parameters (like weight, HbA1C, lipoid profile, insulin sensitivity and sex hormones). They found that erectile function score improved from baseline of 54.85 ± 16.59 to 61.21 ± 14 with P ≤ 0.01 and gonadal function including testosterone level(from 256.36 ± 120.98 in baseline to 508.01±161.90 with P ≤0.01 at 1 year.

There are many studies regarding the nutritional deficiency following bypass surgeries. There is a study of long-term nutritional deficiencies and dietary intake after sleeve gastrectomy or Roux-En-Y gastric bypass in a mediterranean population. It was a longitudinal, prospective and observational study in which primary outcomes were changes in energy, macronutrients, and micronutrients intake and weight loss. They found that the mean daily intake of calcium, magnesium, phosphorus, and iron was less than the current recommendations. The most common observed deficiency is 25-hydroxy vitamin D. On the other hand, there are 2 case reports of night blindness and visual impairment caused by vitamin A deficiency after bariatric surgery which considered a significant complication after mal-absorptive bariatric surgery. Moreover, there is a prospective, single-center, observational study regarding nutritional deficiencies following sleeve gastrectomy with a medium follow up of 2 years. From 100 patients were studied, 48% were supplemented with iron, 33% with zinc, 34% with a combination of calcium carbonate + cholecalciferol, 24% with vitamin D, 42% with vitamin B12, and 40% with folic acid. The patients who received only a sleeve gastrectomy had (Excess weight loss % EWL) of 53.6%, 65.8% and 62.6% after 6, 12 and 24 months, respectively.

Conditions
Quality of Life
Being tested
QoL questionnaire regarding the long term complication
Keywords
Vitamins, Mineral, Surgery
Medical subject headings
Calcinosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QoL questionnaire regarding the long term complicationOther

    Micronutrients evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postsurgical complications

    changes in body weight

    Measured: 1 year

  2. Monitor the HbA1c levels

    Changes in the HbA1c Levels

    Measured: 1 year

Secondary outcomes (5)
  1. Status renal function

    occurrence of renal stone

    Measured: 1 year

  2. Monitor the Iron levels

    Changes in Iron level

    Measured: 1year

  3. Monitor the PTH levels

    changes in the levels of PTH

    Measured: 1year

  4. Monitor the thiamine level

    change in level of thiamine

    Measured: 1 year

  5. Monitor the vitamins B12 levels

    changes in Vitamin B12 levels

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2016 (estimated)
  4. Study completionApr 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02813707
Sponsor's protocol ID
16/008 2016 4272
Acronym
BS-PART2
Status last verified
Jun 2016
First submitted
3 May 2016
Last updated
28 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life, run by United Arab Emirates University at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Prof. Juma AlKaabi, MD, PhD (+97137137472 ext. 472, j.kaabi@uaeu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postsurgical complications (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.

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