Changes in gastrointestinal hormones after bariatric surgery
| ISRCTN | ISRCTN12131308 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12131308 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/01/2016
- Registration date
- 01/02/2016
- Last edited
- 01/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity is a growing problem worldwide. In Spain, around 22.9% of the population is overweight, with 1.8% being dangerously so (morbid obesity). It is well known that obesity can lead to a number of other serious health conditions such as cancer, cardiovascular disease (disease of the heart and blood vessels) and diabetes. By losing excess weight, it is thought that people can dramatically reduce their risk of developing these conditions. Weight loss surgery, also called bariatric surgery, is a drastic measure used to help people who are dangerously overweight and unable to lose weight naturally (through diet and exercise). There are a number of different types of bariatric surgery; however they all work by limiting the amount a person can eat or reducing the number of calories that are absorbed from food. Recent studies have shown that when a person undergoes bariatric surgery, the amounts of different hormones involved in digestion and regulating fat storage change. The specific changes are also thought to be different depending on what type of bariatric surgery is used. This study will look at three different bariatic surgery procedures: gastric bypass surgery (where the stomach is stapled, making it smaller so less food can be eaten), sleeve gastrectomy surgery (where part of the stomach is removed, making the overall size of the stomach smaller) and a procedure called biliopancreatic diversion with duodenal switch (where a large part of the stomach is removed and what remains is connected to the final segment of the small intestine, so food in the intestine has less time to be absorbed). The aim of this study is to compare levels of hormones after eating in adult patients who have had one of these three bariatric surgery procedures, and compare these levels to those of healthy adults with normal weights.
Who can participate?
Adults who have been morbidly obese for at least 5 years and are having bariatric surgery, as well as healthy adults of the same age with a normal weight.
What does the study involve?
At the start of the study, 50 participants due to have bariatric surgery (gastric bypass surgery, sleeve gastrectomy surgery or biliopancreatic diversion with duodenal switch) and 20 healthy participants of a normal weight attend a study visit. At this visit, they are weighted and measured and have a series of blood tests before and 30, 60, 90 and 120 minutes after eating a standard meal so that their hormone levels can be measured. The hormone test is then repeated one year later. For the obese patients, weight is measured at these study visits and again 3 and 5 years after surgery.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants taking part in the study.
Where is the study run from?
San Carlos Clinical Hospital (Spain)
When is the study starting and how long is it expected to run for?
February 2008 to May 2015
Who is funding the study?
1. Biomedical Research foundation of Mutua Madrileña (Spain)
2. Metabolic Studies Foundation, Hospial Clinico San Carlos (Spain)
3. Research in Metabolic and Nutrition Foundation (Spain)
Who is the main contact?
Mrs Patricia Martin
Contact information
Scientific
Servicio de Endocrinologia y Nutrición
Hospital Universitario la Paz
Paseo de la Castellana 261
MADRID
28046
Spain
Study information
| Study design | Prospective single-centre case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Changes in gastrointestinal hormones and its relation with weight loss after gastric bypass, biliopancreatic deviation with duodenal swicht and sleeve gastrectomy: An observational study |
| Study objectives | The aim of this study is to find out whether the physiological hormonal response after a meal test is different in obese and normal weight patients, and whether bariatric surgery can elicit changes in hormonal responses. |
| Ethics approval(s) | Ethics Committee of the Hospital Clínico San Carlos, 24/02/2003, ref: B-03/061 |
| Health condition(s) or problem(s) studied | Morbid obesity |
| Intervention | Morbidity obese patients who are having Roux-en-Y gastric bypass, biliopancreatic deviations with duodenal switch or sleeve gastrectomy are included in the study. Obese and control group have anthropometric and hormonal measurements taken at baseline and 1 year after surgery. At each visit, participants have a blood sample taken, which is repeated 0, 60, 90 and 120 minutes after ingestion of a standard test meal. Obese patients are asked to attend two additional study visits 3 and 5 years after surgery for weight control. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Hormonal response after meal test is measured from blood samples taken at baseline, 30, 60, 90 and 120 minutes after ingestion of a standard test meal, at baseline and one year post surgery. |
| Secondary outcome measures | Weight loss and the height was measured using an electric scale (SECA®) at baseline, 1, 3 and 5 years. |
| Overall study start date | 01/02/2008 |
| Completion date | 31/05/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | A total of 23 patients underwent GB surgery, 17 BPD-DS and 10 SG with a control group of 20 healthy and normal weight volunteers |
| Key inclusion criteria | Obese participant inclusion criteria: 1. Aged between 18 and 65 years 2. BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with associated major comorbidities likely to improve after weight loss 3. That morbid obesity is set for at least 5 years. 4. Continuing failures to properly supervised conservative treatments 5. Ability to understand the mechanisms by which weight is lost with surgery and understand that good results are not always achieved 6. Understand that the goal of surgery is not reach the ideal weight 7. Commitment to adhere to the rules of follow-up after surgery 8. Informed consent after receiving all the (oral and written) information Control participant inclusion criteria: 1. Aged between 18 and 65 years 2. No diabetes mellitus (basal glucose <126 mg/dl and/or Hba1c < 6.5%) 3. BMI <30 and >18 kg/m2 4. No drugs or alcohol abuse. 5. No mayor psychiatric disorders (schizophrenia, psychosis) no eating disorders( anorexia nervosa, bulimia) 6. Informed consent after receiving all the (oral and written) information |
| Key exclusion criteria | 1. Endocrine disorders that can cause morbid obesity. 2. Psychological instability including abuse of alcohol or drugs, major psychiatric disorders (schizophrenia, psychosis), mental retardation, eating disorders (bulimia nervosa, binge eating) 3. Pregnancy |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 30/11/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28040
Spain
Sponsor information
Hospital/treatment centre
Endocrinology and Nutrition Service (Servicio de Endocrinologia y Nutrición)
Calle del Prof Martín Lagos
Madrid
28040
Spain
"ROR" |
https://ror.org/04d0ybj29 |
|---|
Funders
Funder type
Not defined
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 31/07/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Presented as Patricia Martin's PhD project 2. Planned publication in peer reviewed journals |
| IPD sharing plan |
