Epidemiology of Gallbladder Sludge and Stones in Pregnancy

NCT ID: NCT00131131

Last Updated: 2017-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2009-12-31

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.

Conditions

Cholelithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Exercise

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Control

Women in the control group did not attend instructional sessions with the exercise interventionist and did not receive the motivational mailings

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sum P Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Shirley Beresford, PhD

Role: STUDY_DIRECTOR

University of Washington School of Public Health and Community Medicine

Locations

Madigan Army Medical Center

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23456902 (View on PubMed)

Other Identifiers

R01DK046890

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK46890 (completed 2006)

Identifier Type: -

Identifier Source: org_study_id