GallstoneNCT03804775
Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones
An observational study of Gallstone and Dyslipidemias, run by Services Hospital, Lahore at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gallstone, Dyslipidemias
- What is being tested?
- Serum lipid profile
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2017to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Male or female patients with the gall stone disease
- Age from 20 to 70 years
- Gallstones were diagnosed through the ultrasound
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gallstone, Dyslipidemias
- Being tested
- Serum lipid profile
- Medical subject headings
- Gallstones, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| case group | patients presenting with gallstone disease Receives: Diagnostic Test: Serum lipid profile | |
| control group | inpatients with no history of gallstones Receives: Diagnostic Test: Serum lipid profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Aug 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GallstoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Mahmmood Ayyaz, mbbs, fcps, Study director, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804775
- Sponsor's protocol ID
- s10
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Serum Lipid Profiles in Patients With and Without Gallstones: A Prospective Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03804775
- Acronym / sponsor ID
- s10
- Conditions
- Gallstone, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: Serum lipid profilepatients presenting with gallstone disease |
| control group | – | Diagnostic Test: Serum lipid profileinpatients with no history of gallstones |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Male or female patients with the gall stone disease
- Age from 20 to 70 years
- Gallstones were diagnosed through the ultrasound
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum lipid profileBlood 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 | Diagnostic test | case group, control group |
Primary outcome
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmmood Ayyaz, mbbs, fcps study director
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone and Dyslipidemias, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum cholesterol levels (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.