To evaluate phenotypic, genetic, behavioural and environmental characteristics of patients after bariatric surgery and find predictors of response to bariatric surgery. In addition, to compare changes in cardiorespiratory fitness, fat free mass and…
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is to evaluate phenotypic, genetic, behavioural and
environmental characteristics of the included patients.
Secondary outcome
The secondary study endpoint is the difference in cardiorespiratory fitness and
FFM and the relationship of these measurements and muscle function with weight
loss and metabolic health after bariatric surgery. Therefore, the following
additional parameters will be collected before and after surgery:
1. FFM
2. VO2 max
3. Isometric handgrip strength test
Background summary
Obesity is a major public health issue and is associated with several medical
conditions. Excess body weight leads to variable levels of cardiovascular,
pulmonary and skeletal muscle dysfunction resulting in poor cardiorespiratory
fitness. The complexity of the multicausal nature of obesity makes treatment of
this chronic disease difficult. Surgery has proven to be the most effective
treatment for morbid obesity. However, weight loss results vary greatly between
patients and it is unclear what the differences (genetic and metabolic) are
between patients with the highest and patients with the lowest weight loss
after surgery. This study is part of the international, multicentre study:
SOPHIA. The objective of SOPHIA is to optimize treatment outcome of obesity.
Patients will be selected based on the response to treatment (percentage total
weight loss %TWL) 1-2 years after bariatric surgery. The aim of the study is to
compare outcomes and genetic characteristics of patients after surgery.
Study objective
To evaluate phenotypic, genetic, behavioural and environmental characteristics
of patients after bariatric surgery and find predictors of response to
bariatric surgery. In addition, to compare changes in cardiorespiratory
fitness, fat free mass and metabolic status after bariatric surgery and to
evaluate the relationships of cardiorespiratory fitness and muscle function
with weight loss and metabolic health.
Study design
The SOPHIA project is an international, multicentre project. The current study
is part of a cross-sectional study
Study burden and risks
Patients will be invited to visit the clinic for measurements and drawing of
blood. Patients will have an additional of 15mL of blood drawn for GWAS
analyses The visit will take 25 minutes. If the visit is more than 6 months
before the scheduled annual follow up visit, this will be an extra visit to the
NOK for the study purpose. Patient will be informed about this.
GWAS analysis might discover unexpected findings that may effect a patient's
health.
Amersfoortseweg 43
Huis ter Heide 3712 BA
NL
Amersfoortseweg 43
Huis ter Heide 3712 BA
NL
Listed location countries
Age
Inclusion criteria
- Patient is *18 and <75 years old
- Patient is treated at the NOK
- Patient has undergone a primary bariatric procedure
- Patient has at least 18 months of follow-up data and the following essential
parameters are available: weight, BMI, gender and age
Exclusion criteria
Patients who do not understand the patient information letter will be excluded
from participation in this study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | NL 8865 |
| CCMO | NL75166.018.20 |
| OMON | NL-OMON27224 |