Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01930838 |
| Other study ID # |
1-10-72-191-13 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2016 |
| Est. completion date |
August 2016 |
Study information
| Verified date |
September 2013 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater
extent as treatment of obesity to obtain a greater and more permanent weight loss. The
currently most commonly used surgical method is the gastric bypass (RYGB), which so far has
proved to be the most effective way to achieve a greater and more permanent weight loss,
reduction and maybe even elimination of many of the obesity-related health complication
(diabetes, sleep apnea, pain due to osteoarthrosis etc.).
Bariatric surgery, including RYGB is also associated with medical and nutritional
complications. This will be a natural consequence of the fact that the food bypasses
virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after
a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin,
fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the
light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and
vitamin D substitution. In spite of this, many develop various nutritional problems after
RYGB. In addition to these nutritional complications are complications such as hypoglycaemia
and gallstone attacks after RYGB.
Nevertheless there is no comprehensive inventory of the occurrence of nutritional
complications after bariatric surgery neither in Denmark nor in an international context.
Thus there is no consensus on an optimal postoperative prevention of complications. An
overview of the occurrence of these problems will be important for assessing and determine
the indications for bariatric surgery as well as to optimize the prevention of complications.
To enlighten this the investigators will conduct a clinical trial concerning complications
after RYGB. The investigators will examine 350 RYGB operated patients the Central Denmark
Region. From a medical interview, blood tests, Dual energy X-ray absorptiometry etc. it will
be possible to give a good estimate of the incidence of medical complications. The
investigators will explore complications such as: anemia, hypoglycemia, peripheral nerve
problems (especially neuropathies), vitamin D / osteoporosis and other mineral / vitamin
deficiencies that may be identified through blood tests. A control group of 30-40 age, sex
and body mass index matched individuals will go through the same examinations.
Description:
Background Prevalence of overweight and obesity is increasing both in Denmark and in most
other countries, and as conventional treatment of obesity with lifestyle changes (hypocaloric
diet, physical activity and behavior modification) rarely leads to large and sustained weight
loss, it is not surprising that bariatric surgery has taken over more and more of the
treatment of the most severe cases of obesity. Weight losses are greater than with other
treatments, and importantly the relatively large weight loss is permanent. The currently most
commonly used surgical method is the gastric bypass (RYGB), which has proven to be a highly
effective method of achieving a great and permanent weight loss with an approximately 30-40%
reduction in the weight, which is equivalent to 40-60% reduction of the overweight. Moreover
RYGB has shown to provide complete remission of prior type 2 diabetes in up to 80% of cases
at short observation time (up to 2 years after surgery) and about 50% remission at longer
time follow-up (> 5 years).
Moreover data suggest that after GRYGB there is a reduced consumption of antihypertensive
drugs in 51 % an of lipid-lowering drugs in 59 %.
International studies have shown that mortality of bariatric surgery ranges between 0.24 and
2.77% depending on the operator and the hospital, and perioperative morbidity ranges between
6.92 and 8.85% also depending on the operator and the hospital.
There are conflicting results in the literature when examining the consumption of
antidepressants. Some studies find a reduced consumption of antidepressants after bariatric
surgery within the first two years, others show that consumption is almost unchanged overall
and cohort follow-up studies show an increased quality of life.
Nevertheless, there is an increased incidence of suicide after bariatric surgery, which
argues against an unambiguous improvement in psychological well-being.
Bariatric surgery including RYGB is also connected with some medical and nutritional effects
or complications. This is not surprising since RYGB "bypasses" virtually the entire ventricle
and 100-150 cm of the upper part of the small intestine, so problems with the inclusion of,
for example B12, iron, folate, thiamin, fat-soluble vitamins (Vitamin A, D, E and K) copper,
zinc and selenium are expected. Therefore, it is recommended that all RYGB operated patients
substitute vitamin B12, iron and vitamin D. Despite this many develop various nutritional
problems after RYGB, which is sparsely registered in Denmark.
The complications are often developed long time after the operation, at a time when the
patients are no longer followed in specialized departments which report all complications to
the Danish Obesity Register, in the same way as surgical complications are reported. There is
no international consensus on postoperative vitamin substitution, which may be due to the
previous lack of evidence of nutritional complications. This can in the long term result in
irreversible neurological damage, osteoporosis and anemia.
Other classic side effects are early and late dumping, manifested by weakness after a meal or
symptoms of moderate degrees of low blood sugar (hypoglycemia). Frequent bowel movements are
an expected result of a RYGB, but for some patients as much that they are hampered in their
daily activities. Moreover complications such as abdominal pain of varying degree and the
development of gallstones are frequently seen.
It is still unresolved how extensive a problem these nutritional complications after
bariatric surgery in Denmark are, we want to clarify the occurrence of these complications in
Denmark. This will provide an overview of the positive as well as the negative impact of
bariatric surgery and thus will be decisive to assess and determine the indications for
bariatric surgery as well as to optimize the prevention of complications.
The investigators will in this project make a clinical trial by a randomly selected group of
approximately 350 persons in the period 2006-2011, have had RYGB in the Central Region of
Denmark. From a medical interview, blood tests, etc. the investigators will be able to give a
good estimate of the incidence of medical complications. The investigators will explore
complications such as: anemia, hypoglycemia, peripheral nerve problems (especially
neuropathies), vitamin D / osteoporosis and other mineral / vitamin deficiencies that may be
identified through blood tests.
Thus, the investigators wish to achieve a better documentation of both the positive effects
after GYP (weight loss, remission of diabetes, quality of life, etc.) and the negative health
effects (mortality, surgical and nutritional) in order to provide a better founded approach
to this form of treatment.
Method Of the patients who responded to the questionnaire in the second part of the project
450 will be selected randomly to participate in the clinical trial, which will consist of a
thorough medical interview and physical examination including neurological examination
performed by a physician. On suspicion of neurological complications a neurological
examination will performed of a neurological specialist. This part will be conducted in
cooperation with the Neurology Department, Aarhus University Hospital.
There will be taken blood samples of the participants including potassium, sodium,
creatinine, fasting glucose, hemoglobin A1c, albumin, calcium, 25-OH vitamin D, PTH,
β-carotene, vitamin A (retinol), vitamin K (phytomenadione), pp, copper, zinc and selenium,
iron, hemoglobin, ferritin, leukocytes, liver count, and blood and urine investigation of
bone turnover. In addition, patients will be DXA scanned for assessment of bone mineral
content and composition.
To get an appropriate control group, an age / gender / BMI matched control group will also be
established of people who have not been RYGB operated, and this control group of 30-40 people
will undergo exactly the same examinations as the RYGB group.
Statistical considerations and power calculation In the clinical trial we will enroll
approximately 350 patients. Due to practical and financial constraints, this will be the
maximum number of participants it is possible to examine since all will undergo a thorough
individual examination.
Description of participants In our study the investigators will invite 350 patients who have
undergone gastric bypass gastric bypass surgery patients in the Central Denmark Region to
participate.
In addition a healthy control group consisting of 30 to 40 age-, gender-and BMI-matched
individuals who have not undergone RYGB will be examined clinically.
This part of the project will be carried out in cooperation with the Endocrinology and
Metabolism Department, Viborg Regional Hospital.
Risks, side effects and disadvantages The investigators will make a physical examination,
blood tests and Dual energy X-ray absorptiometry which only in rare cases will create a risk
or cause side effects on the subjects. This little risk will largely be offset by the
valuable knowledge that will be achieved.
Respect for the subjects' physical and mental integrity The project is reported to the
region's joint notification to The Danish Data Protection Agency. We hereby declare that the
project is carried out in accordance with the protocol and applicable regulatory /
legislative. The study has been approved of The Regional Committee on Biomedical Research
Ethics in the Central Denmark Region.
The Act on Processing of Personal Data will be respected. The study will also be reported to
The Clinical Trials and conducted in accordance with the Helsinki Declaration II.
Publication of results Both positive, negative and inconclusive results will be published and
sought to be published in English-language, peer-reviewed journals as original publications
and with the PhD student as first author.
Perspectives The investigators expect to identify positive and negative consequences for RYGB
and thus optimize the basis on which patients and physicians in the future will be able to
decide on surgery. This will also better prevention of complications and thus save patients
and communities of loss, economic as well as social and personal. The project will hopefully
form the basis for the continuation of longer follow-up studies. Moreover, the results set
the stage for the development of new more "gentle" obesity surgery.
