Gallbladder Cancer |
|
|
Clinical Trial: Epidemiology of Gallbladder Sludge & Stones in Pregnancy
This study is currently recruiting patients.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) August 2005
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Cholelithiasis | Behavior: exercise | Phase III |
MedlinePlus related topics: Gallbladder Diseases
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Secondary Outcomes: serum insulin and leptin levels
Expected Total Enrollment: 670
Study start: May 2003; Expected completion: February 2007
Last follow-up: December 2006; Data entry closure: 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. We studied the etiological factors associated with the development of sludge and stones during pregnancy, and our early results suggest that it is inversely related to physical activity. We 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, we propose to conduct a randomized controlled trial. This interventional study is a logical extension of our previous observational investigation. Our 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
Accepts Healthy Volunteers
Inclusion Criteria:
Pregnant, over 18, 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
-
Location and Contact Information
Washington
Madigan Army Medical Center, Tacoma, Washington, 98431, United States; Recruiting
Misty Wood (253) 968-3446
Peter Napolitano, MD, Principal Investigator
Sum P Lee, MD, PhD, Principal Investigator, University of Washington
Shirley Beresford, PhD, Study Director, University of Washington School of Publich Health and Community Medicine
More Information
Last Updated: August 16, 2005
Record first received: August 16, 2005
ClinicalTrials.gov Identifier: NCT00131131
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

Not Signed In -


