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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)
August 16, 2005
August 17, 2005
October 6, 2017
May 2003
November 2008   (Final data collection date for primary outcome measure)
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.
gallbladder ultrasound
Complete list of historical versions of study NCT00131131 on ClinicalTrials.gov Archive Site
  • 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
serum insulin and leptin levels
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cholelithiasis
Behavioral: Exercise
  • 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.
    Intervention: 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1196
December 2009
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00131131
DK46890 (completed 2006)
R01DK046890 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Washington
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP