Epidemiology of Gallbladder Sludge and Stones in Pregnancy

Cholelithiasis Clinical Trial

Official title:

Epidemiology of Gallbladder Sludge & Stones in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131131
• Other study ID #: DK46890 (completed 2006)
• Secondary ID: R01DK046890
• Status: Completed
• Phase: N/A
• First received: August 16, 2005
• Last updated: October 5, 2017
• Start date: May 2003
• Est. completion date: December 2009

Study information

• Verified date: October 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1196
• Est. completion date: December 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

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-0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Insulin	Insulin, mU/mL	18 and 36 weeks gestation
Secondary	Leptin	Leptin pg/L	18 and 36 weeks gestation
Secondary	Adiponectin	Adiponectin pg/mL	18 and 36 weeks gestation