Epidemiology of Gallbladder Sludge and Stones in Pregnancy

Epidemiology of Gallbladder Sludge & Stones in Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Cholelithiasis
• Intervention / Treatment: Behavioral: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 1196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Exercise
No Intervention: Control; Women in the control group did not attend instructional sessions with the exercise interventionist and did not receive the motivational mailings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin	Insulin, mU/mL	18 and 36 weeks gestation
Leptin	Leptin pg/L	18 and 36 weeks gestation
Adiponectin	Adiponectin pg/mL	18 and 36 weeks gestation

Collaborators and Investigators

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: University of Washington
• Investigators: Principal Investigator: Sum P Lee, MD, PhD, University of Washington; Study Director: Shirley Beresford, PhD, University of Washington School of Public Health and Community Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 16, 2005
• First Submitted That Met QC Criteria: August 16, 2005
• First Posted (Estimate): August 17, 2005

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: physical activity; cholelithiasis; pregnancy complication
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: DK46890 (completed 2006); R01DK046890 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No