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NCT Number: NCT03804775

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum lipid profile

Diagnostic Test

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

Primary outcomes

  1. serum cholesterol levels

    Time frame: 1 week

    serum cholesterol levels of patients and case group will be compared with Students t- test was (p<0.05 will be considered statistically significant)

  2. serum triglyceride levels

    Time frame: 1 week

    serum triglyceride levels of gallstone patients and control group will be compared via student t-test (p<0.05 was considered statistically significant)

  3. serum HDL levels

    Time frame: 1 week

    serum HDL levels of patients and contoled will be compared with student t-test (p<0.05 was considered statistically significant)

  4. serum LDL leves

    Time frame: 1 week

    serum LDL leves of patients and control will be compared through student t-test (p<0.05 was considered statistically significant)

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 15, 2019
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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