Clinical Trial: Epidemiology of Gallbladder Sludge and Stones in Pregnancy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Summary:
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
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Current Primary Outcome: gallbladder ultrasound
Original Primary Outcome: Same as current
Current Secondary Outcome: serum insulin and leptin levels
Original Secondary Outcome: Same as current
Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dates:
Date Received: August 16, 2005
Date Started: May 2003
Date Completion:
Last Updated: March 17, 2010
Last Verified: March 2010
