Epidemiology of Gallbladder Sludge and Stones in Pregnancy

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00131131
First received: August 16, 2005
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

The specific objective of this project is to study the impact exercise has on gallstone formation during pregnancy when women are at increased risk due to biochemical and physiological alterations.


Condition Intervention Phase
Cholelithiasis
Behavioral: exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Epidemiology of Gallbladder Sludge & Stones in Pregnancy

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • gallbladder ultrasound

Secondary Outcome Measures:
  • serum insulin and leptin levels

Estimated Enrollment: 670
Study Start Date: May 2003
Study Completion Date: December 2006
Detailed Description:

The female gender and multiparity are the two most important positive correlates of cholesterol gallstone disease. Pregnancy represents the period of time when the 'lithogenic' pressure on a woman is the highest. Biliary sludge is a precursor stage of gallstones. The investigators studied the etiological factors associated with the development of sludge and stones during pregnancy, and their early results suggest that it is inversely related to physical activity. They also found that being overweight, a known risk factor for gallstone disease, is associated with high blood leptin levels. In addition, the risk associated with high leptin levels is partially mitigated by physical activity.

In order to disentangle the effects of physical activity, leptin and gestational diabetes on gallbladder disease risk, and to understand the mechanisms behind the observed associations, the investigators propose to conduct a randomized controlled trial. This interventional study is a logical extension of their previous observational investigation. Their specific aims are:

  • To evaluate whether an endurance exercise program is associated with lower risk of gallbladder disease in overweight pregnant women;
  • To evaluate whether an endurance exercise intervention program changes leptin levels in pregnancy among overweight women;
  • To examine the associations between gallbladder disease incidence and potential causal variables in this prospective trial. These variables include leptin levels, HDL, insulin levels, BMI (as it varies within women classified as overweight), as well as changes in these variables.

Gallstone disease affects 15-20% of adult Americans. Cholecystectomy is one of the most commonly performed operations. The morbidity, and the burden of cost, incurred by gallstones are staggering. Yet there is a dearth of understanding in the epidemiology and the cause of this disease. The results of this investigation should generate new, important and useful insights into the pathogenesis, and provide a rational strategy for the prevention, of this common and costly disease.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Over 18 years of age
  • Eligible for care at Madigan Army Medical Center

Exclusion Criteria:

  • Prior gallbladder surgery
  • Non-English speaking
  • Medical reason not to exercise during pregnancy
  • Moving from area within 3 months
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00131131

Locations
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Investigators
Principal Investigator: Sum P Lee, MD, PhD University of Washington
Study Director: Shirley Beresford, PhD University of Washington School of Public Health and Community Medicine
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131131     History of Changes
Other Study ID Numbers: DK46890 (completed 2006)
Study First Received: August 16, 2005
Last Updated: March 17, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
physical activity
cholelithiasis
pregnancy complication

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 23, 2014