Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study - Full Text View

Purpose

By affecting the gastroesophageal pressure gradient, obesity predisposes to reflux of gastric contents. The investigators hypothesized that the loss of weight will decrease this gradient and as a result decrease the severity and frequency of GERD symptoms. GERD negatively affects health related quality of life. Since loss of weight may decrease gastroesophageal reflux, the investigators hypothesized that it obesity contributes to poor quality of life in GERD subjects and losing weight should also favorably impact and improve quality of life in GERD patients.

Condition	Intervention	Phase
GERD Obesity	Behavioral: Self support, group sessions, meal replacement therapy	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: GERD Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:

Impact of Weight loss on GERD symptoms [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Impact of weight loss on quality of life and GERD symptoms [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2009
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Obese individuals with weight loss Obese individuals with weight loss	Behavioral: Self support, group sessions, meal replacement therapy Self support,group sessions,meal replacement therapy
Experimental: Obese individuals without weight loss Obese individuals without weight loss	Behavioral: Self support, group sessions, meal replacement therapy Self support,group sessions,meal replacement therapy

Detailed Description:

The current proposal is a prospective, observational cohort study This study aims to determine the impact of structured weight loss (MOVE program) on GERD symptoms in overweight and obese veterans enrolled in a MOVE program. Successful weight loss will be defined as loss of 10% or higher baseline weight at 6 months follow up. Cases will be defined as subjects who achieved successful weight loss and controls as those who did not. GERD symptoms in subjects who lose weight (cases) will be compared to those with no weight loss (controls). Validated GERQ, RDQ and QOLRAD questionnaires will be used to assess prevalence of GERD symptoms, QOL and impact of weight loss on these symptoms. All MOVE participants will complete a validated GERQ, RDQ and QOLRAD questionnaires at baseline MOVE clinic visit and RDQ and QOLRAD during their follow up visits. Patient's total RDQ scores at baseline and follow up visits will be used to determine change in frequency and severity of GERD symptoms with weight loss, similarly change in the total QOLRAD questionnaire scores from baseline will be used to assess change in HRQOL with weight loss. Apart from information provided in MOVE!23, GERQ, RDQ and QOLRAD questionnaires, relevant information pertaining to obesity and GERD association will be obtained from patient's computerized medical records.

The impact of weight loss on GERD symptoms will be assessed. The impact of weight loss on QOL and GERD medication usage among MOVE participants will be assessed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Must be a Kansas City Veterans Hospital patient who is enrolled in the MOVE weight loss program
Patients with a BMI > 25 with associated co—morbid medical conditions such as diabetes, high blood pressure, high cholesterol, arthritis, heart disease, low back pain, sleep apnea, or other obesity associated condition.
Enrollment in MOVE program is optional for patients with a BMI > 25 with no co-morbid medical conditions.
Enrollment for patients 70 years or older with BMI > 25 is optional and requires mandatory medical clearance prior to beginning new physical activity and closer nutritional supervision to minimize protein, vitamin and mineral deficiencies.

Exclusion Criteria:

Active cancer other than non-melanoma skin cancer
End stage COPD, congestive heart failure
End stage neurologic disorder (Parkinson's, ALS, MS)
Long-term care facility resident
End stage renal disease
Moderate to severe cognitive impairment (dementia, post-stroke)
Active psychosis or substance abuse
AIDS (except asymptomatic HIV infection)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574573

Contacts

Contact: April Higbee, RN,BSN

816-861-4700 ext 57456

april.higbee@va.gov

Locations

United States, Kansas
Topeka VA Medical Center	Recruiting
Topeka, Kansas, United States, 66622
Contact: David Scharpenburg, RD 785-350-3111
Principal Investigator: David Scharpenburg, RD
United States, Missouri
Kansas City VA Medical Center	Recruiting
Kansas City, Missouri, United States, 64128
Contact: April Higbee, RN,BSN 816-861-4700 april.higbee@va.gov
Principal Investigator: Prateek Sharma, MD
Sub-Investigator: Amit Rastogi, MD
Sub-Investigator: Mandeep Singh, MD

Sponsors and Collaborators

Midwest Biomedical Research Foundation

Kansas City Veteran Affairs Medical Center

Investigators

Principal Investigator:

Prateek Sharma, MD

Kansas City VA Medical Center

More Information

Publications:

Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005 May;54(5):710-7. Review.

Kulig M, Nocon M, Vieth M, Leodolter A, Jaspersen D, Labenz J, Meyer-Sabellek W, Stolte M, Lind T, Malfertheiner P, Willich SN. Risk factors of gastroesophageal reflux disease: methodology and first epidemiological results of the ProGERD study. J Clin Epidemiol. 2004 Jun;57(6):580-9.

McDougall NI, Johnston BT, Kee F, Collins JS, McFarland RJ, Love AH. Natural history of reflux oesophagitis: a 10 year follow up of its effect on patient symptomatology and quality of life. Gut. 1996 Apr;38(4):481-6.

Talley NJ, Fullerton S, Junghard O, Wiklund I. Quality of life in patients with endoscopy-negative heartburn: reliability and sensitivity of disease-specific instruments. Am J Gastroenterol. 2001 Jul;96(7):1998-2004.

Kulig M, Leodolter A, Vieth M, Schulte E, Jaspersen D, Labenz J, Lind T, Meyer-Sabellek W, Malfertheiner P, Stolte M, Willich SN. Quality of life in relation to symptoms in patients with gastro-oesophageal reflux disease-- an analysis based on the ProGERD initiative. Aliment Pharmacol Ther. 2003 Oct 15;18(8):767-76.

Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56.

Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6.

El-Serag HB, Kvapil P, Hacken-Bitar J, Kramer JR. Abdominal obesity and the risk of Barrett's esophagus. Am J Gastroenterol. 2005 Oct;100(10):2151-6. PubMed PMID: 16181362.

El-Serag HB. Time trends of gastroesophageal reflux disease: a systematic review. Clin Gastroenterol Hepatol. 2007 Jan;5(1):17-26. Epub 2006 Dec 4. Review.

Fisher BL, Pennathur A, Mutnick JL, Little AG. Obesity correlates with gastroesophageal reflux. Dig Dis Sci. 1999 Nov;44(11):2290-4.

Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55.

Murray L, Johnston B, Lane A, Harvey I, Donovan J, Nair P, Harvey R. Relationship between body mass and gastro-oesophageal reflux symptoms: The Bristol Helicobacter Project. Int J Epidemiol. 2003 Aug;32(4):645-50.

Responsible Party:	PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:	NCT01574573 History of Changes
Other Study ID Numbers:	PS0054
Study First Received:	April 6, 2012
Last Updated:	October 25, 2012
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by Midwest Biomedical Research Foundation:

Obesity
GERD
Weight loss

Additional relevant MeSH terms:

Gastroesophageal Reflux
Obesity
Weight Loss
Overweight
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases

Gastrointestinal Diseases
Digestive System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on June 18, 2013