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| Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00131131 |
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 | Phase |
|---|---|---|
|
Cholelithiasis |
Behavioral: exercise |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Epidemiology of Gallbladder Sludge & Stones in Pregnancy |
| Estimated Enrollment: | 670 |
| Study Start Date: | May 2003 |
| Study Completion Date: | December 2006 |
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:
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| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
| 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
| Study ID Numbers: | DK46890 |
| Study First Received: | August 16, 2005 |
| Last Updated: | February 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00131131 History of Changes |
| Health Authority: | United States: Federal Government |
|
physical activity cholelithiasis pregnancy complication |
|
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases Pregnancy Complications |
Cholelithiasis Gallstones Biliary Tract Diseases Calculi |
|
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases |
Cholelithiasis Gallstones Biliary Tract Diseases Calculi |