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Epidemiology of Gallbladder Sludge and Stones in Pregnancy

Epidemiology of Gallbladder Sludge & Stones in Pregnancy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131131
Enrollment
1196
Registered
2005-08-17
Start date
2003-05-31
Completion date
2009-12-31
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis

Keywords

physical activity, cholelithiasis, pregnancy complication

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.

Interventions

BEHAVIORALExercise

Sponsors

University of Washington
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Development of gall bladder sludge or gallstones18 and 36 weeks gestationGallbladder 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.

Secondary

MeasureTime frameDescription
Insulin18 and 36 weeks gestationInsulin, mU/mL
Leptin18 and 36 weeks gestationLeptin pg/L
Adiponectin18 and 36 weeks gestationAdiponectin pg/mL

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026