The primary aim of this study is to assess the effect of weight loss in obese subjects, brought about by non-surgical methods, on all types of gastroesophageal reflux (gaseous, liquid and mixed, acid and nonacid), as measured by ambulatory pH/…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in reflux symptoms and objective measurements of gastroesophageal
reflux (time pH < 4, number of reflux episodes) before and after 10% weight
loss.
Secondary outcome
- Basal LES pressure
- Incidence of TLESR's
- Number of acid and non-acid ('weakly acidic') reflux episodes
- Symptom Association Probability
- Diary Report
Background summary
A high body mass index (BMI) has been shown to be associated with an elevated
risk of gastroesophageal reflux disease (GERD). A specific dose-relationship
between increasing BMI and the prevalence of GERD has been demonstrated. Weight
loss, along with other life style advice, is often recommended as part of the
first-line management of gastroesophageal reflux. However, the beneficial
effect of weight reduction has not been demonstrated unequivocally.
Study objective
The primary aim of this study is to assess the effect of weight loss in obese
subjects, brought about by non-surgical methods, on all types of
gastroesophageal reflux (gaseous, liquid and mixed, acid and nonacid), as
measured by ambulatory pH/impedance monitoring.
The secondary aim of the study is to investigate the effect of weight reduction
on reflux symptoms and on the mechanisms underlying reflux.
Study design
In a prospective study the subjects will undergo two assessments to investigate
the severity of their gastroesophageal reflux, reflux symptoms and the
mechanisms underlying reflux, once before the start of a weight reduction
program and once after a weight loss of at least 10% of their initial weight.
Study burden and risks
Participation in the study implies that the patient has to travel to the UMC
Utrecht. At the start of the study and after a weight loss of 10% their
gastroesophageal reflux will be assessed with 3-hour stationary esophageal
manometry 24 hour pH-metry. The risk associated with these procedures is nil.
Careful assessment of reflux might lead to more appropriate therapy than
otherwise offered.
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Men and women > 18 years of age
- BMI > 30 kg/m2
Exclusion criteria
- Medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, theophylline, calcium blocking agents, opioids)
- Severe concomitant disease
- Extended abdominal surgery in the past
- Present motility disorders
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL24064.041.08 |