Clinical trial NCT00131131: Epidemiology of Gallbladder Sludge and Stones in Pregnancy
Official title: Epidemiology of Gallbladder Sludge & Stones in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Keywords: physical activity
cholelithiasis
pregnancy complication
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of Washington
First posted: 2005-08-17
Enrollment: 1196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of gall bladder sludge or gallstones
timeFrame: 18 and 36 weeks gestation
Secondary outcomes:
measure: Insulin
timeFrame: 18 and 36 weeks gestation
measure: Leptin
timeFrame: 18 and 36 weeks gestation
measure: Adiponectin
timeFrame: 18 and 36 weeks gestation
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Sum P Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington School of Public Health and Community Medicine
name: Shirley Beresford, PhD
role: STUDY_DIRECTOR
References:
citation: 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.