NCT03804775

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

January 9, 2019

Last Update Submit

January 14, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

case group

patients presenting with gallstone disease

Diagnostic Test: Serum lipid profile

control group

inpatients with no history of gallstones

Diagnostic Test: Serum lipid profile

Interventions

Serum lipid profileDIAGNOSTIC_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

case groupcontrol group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Male or female patients with the gall stone disease
  • Age from 20 to 70 years
  • Gallstones were diagnosed through the ultrasound

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

GallstonesDyslipidemias

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Mahmmood Ayyaz, mbbs, fcps

    Services Hospital, Lahore

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 15, 2019

Study Start

August 1, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations