Epidemiology of Gallbladder Sludge and Stones in Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Epidemiology of Gallbladder Sludge & Stones in Pregnancy

Conditions
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Cholelithiasis

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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. | Behavioral: Exercise<br> <br> |
| No Intervention: Control<br>Women in the control group did not attend instructional sessions with the exercise interventionist and did not receive the motivational mailings | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of gall bladder sludge or gallstones | 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. | 18 and 36 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin | Insulin, mU/mL | 18 and 36 weeks gestation | 
| Leptin | Leptin pg/L | 18 and 36 weeks gestation | 
| Adiponectin | Adiponectin pg/mL | 18 and 36 weeks gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, cholelithiasis, pregnancy complication