Epidemiology of Gallbladder Sludge and Stones in Pregnancy

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.

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