Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131131
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2005-08-16
Brief Title:
Epidemiology of Gallbladder Sludge and Stones in Pregnancy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Epidemiology of Gallbladder Sludge Stones in Pregnancy
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK046890 | NIH | None | httpsreporternihgovquickSearchR01DK046890 |