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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK046890 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | 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. |
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| Control | No Intervention | Women in the control group did not attend instructional sessions with the exercise interventionist and did not receive the motivational mailings |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin | Insulin, mU/mL | 18 and 36 weeks gestation |
| Leptin | Leptin pg/L | 18 and 36 weeks gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sum P Lee, MD, PhD | University of Washington | Principal Investigator |
| Shirley Beresford, PhD | University of Washington School of Public Health and Community Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23456902 | Result | 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. |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D009043 | Motor Activity |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Adiponectin | Adiponectin pg/mL | 18 and 36 weeks gestation |
| D000091642 | Urogenital Diseases |