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.
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.
United Arab Emirates1 site, 1 recruiting
- 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
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.
Postsurgical complications
changes in body weight
Measured: 1 year
Monitor the HbA1c levels
Changes in the HbA1c Levels
Measured: 1 year
Secondary outcomes (5)
Status renal function
occurrence of renal stone
Measured: 1 year
Monitor the Iron levels
Changes in Iron level
Measured: 1year
Monitor the PTH levels
changes in the levels of PTH
Measured: 1year
Monitor the thiamine level
change in level of thiamine
Measured: 1 year
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.
- First posted27 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juma Alkaabi, United Arab Emirates University
- Investigators
- Salah Gariballa, MD, Study chair, United Arab Emirates University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Determine Long Term Impact of Bariatric Surgery on Metabolic, Nutritional and Quality of Life Status: PART 2
- ClinicalTrials.gov ID
- NCT02813707
- Acronym / sponsor ID
- BS-PART2 / 16/008 2016 4272
- Conditions
- Quality of Life
- Keywords
- Vitamins, Mineral, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All adult patients who underwent any type of bariatric surgery at Tawam Hospital with at least 12 months duration post-operative
Key exclusion criteria (2 listed)
- Not willing to participate in the study.
- No show
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QoL questionnaire regarding the long term complicationMicronutrients evaluation | Other | – |
Primary outcome
Postsurgical complications
Time frame: 1 year
changes in body weight
Monitor the HbA1c levels
Time frame: 1 year
Changes in the HbA1c Levels
5 secondary outcomes
Status renal function
Time frame: 1 year
Monitor the Iron levels
Time frame: 1year
Monitor the PTH levels
Time frame: 1year
Monitor the thiamine level
Time frame: 1 year
Monitor the vitamins B12 levels
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Gariballa, MD study chair
United Arab Emirates University
1 site in 1 country: see every site and its status.
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.