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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Gallstone
• Intervention / Treatment: Diagnostic test: Serum lipid profile

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Case group: patients from lahore city presented with gallstone disease in Services Hospital lahore

Control group: Patients admitted to Services Hospital with other diseases belonging from lahore

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case group; patients presenting with gallstone disease	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
control group; inpatients with no history of gallstones	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Pathological Conditions, Anatomical; Lipid Metabolism Disorders; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Dyslipidemias; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: s10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No