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Epidemiology of Gallbladder Sludge and Stones in Pregnancy

This study has been completed.
Study NCT00131131.   Last updated on February 21, 2008.   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Descriptive Information Fields
Brief Title  Epidemiology of Gallbladder Sludge and Stones in Pregnancy
Official Title  Epidemiology of Gallbladder Sludge & Stones in Pregnancy
Brief Summary

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.

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure  gallbladder ultrasound
Secondary Outcome Measure  serum insulin and leptin levels
Condition  Cholelithiasis
Intervention  Behavioral: exercise
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  670
Start Date  May 2003
Completion Date December 2006
Eligibility 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
Gender Female
Ages 18 Years to 50 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00131131
Organization ID DK46890
Secondary IDs ††
Study Sponsor  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    
Information Provided By National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date February 2008
First Received Date  August 16, 2005
Last Updated Date February 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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