The first aim is to determine the amount of nocturnal reflux (reflux time / 24 h) in obese subjects compared to normal weight subjects. Secondary objectives are to identify possible mechanisms which cause nocturnal reflux in this patient group and…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in nocturnal reflux pattern (reflux time / 24 h, frequency of
reflux episodes, LES pressure) between obese and normal-weight subjects with
GERD.
Secondary outcome
n.v.t.
Background summary
More than half of patients with chronic gastroesophageal reflux (GERD) report
nocturnal symptoms. Consequences of nocturnal reflux include poor sleep
quality, daytime fatigue, difficulty initiating sleep or arousals from sleep,
and impaired work productivity.
A dose-dependent relationship between obesity and reflux was described before.
Several mechanisms -among others increased intragastric pressure, the presence
of a hiatus hernia and more frequent TLESRs - play a role in this relation. In
this study, the role of obesity in the pathophysiology of nocturnal acid reflux
will be assessed. This has not been studied before. Our hypothesis is that
obese subjects -as compared to lean GERD patients- will have more
gastroesophageal reflux during the night. The above mentioned factors will
contribute to this increase.
Study objective
The first aim is to determine the amount of nocturnal reflux (reflux time / 24
h) in obese subjects compared to normal weight subjects.
Secondary objectives are to identify possible mechanisms which cause nocturnal
reflux in this patient group and to identify the relation between
anthropometric parameters (BMI and waist circumference) and the reflux pattern.
Study design
In a prospective study, the nocturnal reflux pattern will be assessed; pH-
monitoring and high resolution manometry will be carried out overnight.
Esophageal impedance will also be measured to assess the role of non-acid and
gaseous nocturnal reflux. Patients will be admitted to the hospital for one
night, because the combination of these measurements can not be done
ambulatory.
Study burden and risks
Patients will undergo nocturnal pH-metry and high resolution manometry.
Therefore they will be admitted for one night in the UMC Utrecht. The
combination of these probes is necessary to determine the role of LES integrity
and esophageal peristalsis in the pathogenesis of obesity. The risk associated
with these procedures is limited. In the literature several studies with
combined ph-metry and manometry can be found. The probes are -generaly
speaking- tolerated normal during sleep.
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Man and woman > 18 years of age
- Proven nocturnal GERD (pH < 4 during > 3 % of supine position)
- Non-obese subjects: BMI 18.5-24.9 kg/m2
- Obese subjects: BMI > 30 kg/m2
Exclusion criteria
- Pre-existent esophageal motility disorders
- Proven obstructive sleep apnea with CPAP therapy
- Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, theophylline, calcium blocking agents, opioids)
Design
Recruitment
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 | NL30255.041.09 |