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

August 16, 2005
March 17, 2010
May 2003
Not Provided
gallbladder ultrasound
Same as current
Complete list of historical versions of study NCT00131131 on ClinicalTrials.gov Archive Site
serum insulin and leptin levels
Same as current
Not Provided
Not Provided
 
Epidemiology of Gallbladder Sludge and Stones in Pregnancy
Epidemiology of Gallbladder Sludge & Stones in Pregnancy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
Cholelithiasis
Behavioral: exercise
Not Provided
Ko CW, Napolitano PG, Lee SP, Schulte SD, Ciol MA, Beresford SA. Physical activity, maternal metabolic measures, and the incidence of gallbladder sludge or stones during pregnancy: a randomized trial. Am J Perinatol. 2014 Jan;31(1):39-48. doi: 10.1055/s-0033-1334455. Epub 2013 Mar 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
670
December 2006
Not Provided

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131131
DK46890 (completed 2006)
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP