Epidemiology of Gallbladder Sludge and Stones in Pregnancy
|ClinicalTrials.gov Identifier: NCT00131131|
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Epidemiology of Gallbladder Sludge & Stones in Pregnancy|
|Study Start Date :||May 2003|
|Primary Completion Date :||November 2008|
|Study Completion Date :||December 2009|
The intervention was an exercise program of moderate to vigorous intensity. The intervention started with 30-minute sessions three times per week, with the ultimate goal to have participants exercise four to five times per week for 45 to 60 minutes per session.
No Intervention: Control
Women in the control group did not attend instructional sessions with the exercise interventionist and did not receive the motivational mailings
- Development of gall bladder sludge or gallstones [ Time Frame: 18 and 36 weeks gestation ]Gallbladder sludge was defined as the presence of low amplitude echoes within the gallbladder without postacoustic shadowing, which could layer with positioning of the patient. Gallstones were defined as high amplitude echoes with postacoustic shadowing.
- Insulin [ Time Frame: 18 and 36 weeks gestation ]Insulin, mU/mL
- Leptin [ Time Frame: 18 and 36 weeks gestation ]Leptin pg/L
- Adiponectin [ Time Frame: 18 and 36 weeks gestation ]Adiponectin pg/mL
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131131
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|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|