The first aim is to identify possible mechanisms which cause nocturnal reflux in obese subjects. Secondary aims are to identify the role of weight reduction on reflux parameters and to identify the relation between anthropometric parameters (BMI and…
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- nocturnal reflux pattern (supine reflux, number of reflux episodes, LES
pressure)
- LES pressure during reflux episodes
- esophageal clearance
Secondary outcome
Esophageal high resolution manometry
- basal LES pressure
- gastroesophageal pressure gradient
- distal esophageal contractil integral (parameter which quantifies the
esophageal contraction)
pH-impedance signals
- percentage non-acid reflux
- bolus transit time
- Symptom Association Probability (SAP-score)
Background summary
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.
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.
Decreased esophageal clearance may play a role in the pathogenesis of nocturnal
heartburn. This and other pathofysiologic phenomenons are not thoroughly
studied in obese subjects. The aim of this protocol is to study this during the
night and to identify the role of weight reduction on noctunal reflux in these
subjects.
Study objective
The first aim is to identify possible mechanisms which cause nocturnal reflux
in obese subjects.
Secondary aims are to identify the role of weight reduction on reflux
parameters 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 in obese
subjects; pH- monitoring and high resolution manometry will be carried out
overnight, before and after a period of weight reduction (interval 8 months).
Esophageal impedance can 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, because the
combination of these measurements can not be done ambulatory. The combination
of these probes is necessary to determine the role of LES integrity and
esophageal peristalsis in the pathogenesis of nocturnal reflux. 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)
- 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 | NL32508.041.10 |