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Influence between weight loss and improvement of symptoms in patients with reflux disease to the esophagus (occurs when the stomach contents back to the esophagus)

Influence between weight loss and improvement of symtoms in patientes with gastroesophageal reflux disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3cfcyc
Enrollment
Unknown
Registered
2016-11-21
Start date
2012-09-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux disease and obesity

Interventions

62 patients will be recruited. Patients will be randomized in blocks of 10 and divided into two groups. Intervention group (31 patients): Will receive nutritional intervention with low-calorie diet, t
Other

Sponsors

Universidade Federal do Rio Grande do Sul - UFRGS
Lead Sponsor
Universidade Federal do Rio Grande do Sul - UFRGS
Collaborator

Eligibility

Age
No minimum to 99 Years

Inclusion criteria

Inclusion criteria: Both sexes; age over 18 years; BMI greater than 25m ² / kg; that are experiencing typical symptoms (heartburn or regurgitation) 1 x per week or more;presence of diagnosis, confirmed by endoscopy and treatment of GERD; voluntary agreement to participate in the study.

Exclusion criteria

Exclusion criteria: Hospitalized patients; pregnant / lactating; patients who underwent surgery of the esophagus and / or stomach; cognitive inability to understand the guidelines; chronic diseases such as cancer and diabetes mellitus;presence of hiatal hernia; refractory to drug treatment; presence of complicated GERD with esophagitis grade C or D; presence of Barrett's esophagus; patient's wish to opt for surgical treatment.

Design outcomes

Primary

MeasureTime frame
Improvement of symptoms of gastroesophageal reflux disease. Participants answered the QS-GERD Symptoms Questionnaire of Gastroesophageal Reflux Disease (GERD-QS) in which the maximum score is 55 points. This questionnaire consists of 11 questions, 10 of them answered according to a scale of 0 to 5, with the following meanings: 0, absence of symptoms; 1, symptoms without repercussion no day-to-day patient; and so gradually ate 5 indicates que que constants symptoms interfere with daily activities of patients. Statistical analysis were considered the first and last assessment to which each patient was submitted. The comparison between groups was performed by Student's t test. To control confounding factors, Analysis of Covariance (ANCOVA) was applied. The significance level was 5% (p 0.05).

Secondary

MeasureTime frame
Improvement of symptoms of gastroesophageal reflux disease. Participants answered the QS-GERD Symptoms Questionnaire of Gastroesophageal Reflux Disease (GERD-QS) in which the maximum score is 55 points. This questionnaire consists of 11 questions, 10 of them answered according to a scale of 0 to 5, with the following meanings: 0, absence of symptoms; 1, symptoms without repercussion no day-to-day patient; and so gradually ate 5 indicates que que constants symptoms interfere with daily activities of patients. Statistical analysis were considered the first and last assessment to which each patient was submitted. The comparison between groups was performed by Student's t test. To control confounding factors, Analysis of Covariance (ANCOVA) was applied. The significance level was 5% (p 0.05).

Countries

Brazil

Contacts

Public ContactDaieni Fernandes

Universidade Federal do Rio Grande do Sul - UFRGS

daienifernandes@msn.com+55 (51) 3308 5616

Outcome results

None listed

Source: REBEC (via WHO ICTRP)