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Epidemiology of Gallbladder Sludge and Stones in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131131
First Posted: August 17, 2005
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Washington
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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.

Condition Intervention
Cholelithiasis Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Epidemiology of Gallbladder Sludge & Stones in Pregnancy

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Development of gall bladder sludge or gallstones [ Time Frame: 18 and 36 weeks gestation ]
    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.


Secondary Outcome Measures:
  • Insulin [ Time Frame: 18 and 36 weeks gestation ]
    Insulin, mU/mL

  • Leptin [ Time Frame: 18 and 36 weeks gestation ]
    Leptin pg/L

  • Adiponectin [ Time Frame: 18 and 36 weeks gestation ]
    Adiponectin pg/mL


Enrollment: 1196
Study Start Date: May 2003
Study Completion Date: December 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131131


Locations
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
  More Information

Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00131131     History of Changes
Other Study ID Numbers: DK46890 (completed 2006)
R01DK046890 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2005
First Posted: August 17, 2005
Last Update Posted: October 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
physical activity
cholelithiasis
pregnancy complication

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical