Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones

Dyslipidemias Clinical Trial

Official title:

Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones: A Prospective Cross-Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804775
• Other study ID #: s10
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: August 30, 2018

Study information

• Verified date: January 2019
• Source: Services Hospital, Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gallbladder disease is one of the most common diseases of the gastrointestinal tract. Various studies have shown an association between gallstones and an alteration in the serum lipids. The objective of this study will be to compare serum lipid profile of gallstone patients with the controls.

Description:

This prospective cross-sectional study will be conducted in the Surgical Department of the Services Institute of Medical Sciences. A total of 50 patients will beincluded in the study after screening through the inclusion criteria. A control group of 50 inpatients with no personal or family history of gallstones will be also recruited for comparison. Results will be expressed as mean with standard deviation. Students t- test will be used to compare the data between the patients and the control groups (p<0.05 will be considered statistically significant). SPSS software, version 20 will be used for statistical analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female patients with the gall stone disease

• Age from 20 to 70 years

• Gallstones were diagnosed through the ultrasound

Exclusion Criteria:

• Patients with acalculous gallbladder disease on ultrasound,

• Patients with terminal ileal resection,

• Patients with hemolytic diseases (hereditary spherocytosis, sickle cell anemia on history and CBC film),

• Patients with liver cirrhosis (on abdominal ultrasound) and

• Patients on antihyperlipidemic drugs

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Dyslipidemias
• Gallstone
• Gallstones

Intervention

Diagnostic Test:
• Serum lipid profile
Blood samples drawn from the patients and controls will be analyzed for serum cholesterol, serum triglycerides, serum LDLs and serum HDL levels. All the results will be recorded on a performa

Locations

Country	Name	City	State
Pakistan	Services hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Services Hospital, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum cholesterol levels	serum cholesterol levels of patients and case group will be compared with Students t- test was (p<0.05 will be considered statistically significant)	1 week
Primary	serum triglyceride levels	serum triglyceride levels of gallstone patients and control group will be compared via student t-test (p<0.05 was considered statistically significant)	1 week
Primary	serum HDL levels	serum HDL levels of patients and contoled will be compared with student t-test (p<0.05 was considered statistically significant)	1 week
Primary	serum LDL leves	serum LDL leves of patients and control will be compared through student t-test (p<0.05 was considered statistically significant)	1 week