Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250673
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-11-23
Brief Title:
Effect of Different Diets on Isotretinoin Users to Serum Lipid Levels
Sponsor:
Igdir University
Organization:
Igdir University
Study Overview
Official Title:
The Effect of the Mediterranean Diet and Low Cholesterol Diet on Serum Lipid Levels in Individuals Receiving Isotretinoin Treatment
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research was planned to prevent secondary hyperlipidemia which may occur due to isotretinoin used in the treatment of severe acne with diet There will be three different groups and followed for 12 weeks Groups will be Mediterranean Diet Low Cholesterol Diet 200 mgday and the Control Group
Detailed Description:
Isotretinoin has been officially used to treat severe cystic acne since the 1980s The drug is a retinoic acid derivative and works by reducing the size of the sebaceous glands and sebum production Thanks to this effect the lipid profile on the skin surface changes and the bacterial skin flora decreases
The drug also has a side effect of increasing blood lipids causing secondary hyperlipidemia This research examines the effects of low cholesterol diet and Mediterranean diet on blood lipids which are implemented to prevent the increase of blood lipids
The research was designed as an experimental intervention research and will conducted at Nevruz Erez State Hospital Skin and Venereology Polyclinics between November 2023 and April 2024 with volunteers who meet the research criteria
H0 Secondary hyperlipidemia due to isotretinoin use cannot be prevented by diet
H1 Secondary hyperlipidemia due to isotretinoin use can be prevented by diet People who volunteer to participate in the research will be informed in detail about the research with the Informed Consent Form and then will be grouped by the list method At the beginning of the research the Personal Information Form the Mediterranean Diet Adherence Scale and the Food Consumption Frequency form prepared by the researcher will be applied to all patients who volunteer to participate in the research The results of Biochemistry and Hemogram tests performed by the doctor will be recorded
During the research the blood findings Total Cholesterol HDL-Cholesterol LDL-Cholesterol Triglyceride ALT AST and Hemogram of the patients in each group will be checked monthly by the Skin and Venereology Polyclinic Physician who follows their treatment and the patients isotretinoin doses will be completely adjusted by the doctor No intervention other than diet will be made by the researcher
Sample size of the study n Effect size d 094 significance level α 005 power of the test 1-β 80 were entered into the Gpower program and calculated as 32n for two groups This research will be conducted with three different groups in this case it is planned to complete the research on a total of at least 48 patients namely the Mediterranean Diet Group n1 16 the Low Cholesterol Diet Group n2 16 and the Control Group n3 16
Considering that the research period is 12 weeks 25 more people will be recruited for each group in case the patients leave the study or are excluded from the research In this situation Mediterranean Diet Group n1 20 people Low Cholesterol Diet Group n2 20 people Control Group n3 20 people Total Sample Size n 60 people The total research duration for all groups participating in the research is planned to be 12 weeks
The drug also has a side effect of increasing blood lipids causing secondary hyperlipidemia This research examines the effects of low cholesterol diet and Mediterranean diet on blood lipids which are implemented to prevent the increase of blood lipids
The research was designed as an experimental intervention research and will conducted at Nevruz Erez State Hospital Skin and Venereology Polyclinics between November 2023 and April 2024 with volunteers who meet the research criteria
H0 Secondary hyperlipidemia due to isotretinoin use cannot be prevented by diet
H1 Secondary hyperlipidemia due to isotretinoin use can be prevented by diet People who volunteer to participate in the research will be informed in detail about the research with the Informed Consent Form and then will be grouped by the list method At the beginning of the research the Personal Information Form the Mediterranean Diet Adherence Scale and the Food Consumption Frequency form prepared by the researcher will be applied to all patients who volunteer to participate in the research The results of Biochemistry and Hemogram tests performed by the doctor will be recorded
During the research the blood findings Total Cholesterol HDL-Cholesterol LDL-Cholesterol Triglyceride ALT AST and Hemogram of the patients in each group will be checked monthly by the Skin and Venereology Polyclinic Physician who follows their treatment and the patients isotretinoin doses will be completely adjusted by the doctor No intervention other than diet will be made by the researcher
Sample size of the study n Effect size d 094 significance level α 005 power of the test 1-β 80 were entered into the Gpower program and calculated as 32n for two groups This research will be conducted with three different groups in this case it is planned to complete the research on a total of at least 48 patients namely the Mediterranean Diet Group n1 16 the Low Cholesterol Diet Group n2 16 and the Control Group n3 16
Considering that the research period is 12 weeks 25 more people will be recruited for each group in case the patients leave the study or are excluded from the research In this situation Mediterranean Diet Group n1 20 people Low Cholesterol Diet Group n2 20 people Control Group n3 20 people Total Sample Size n 60 people The total research duration for all groups participating in the research is planned to be 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None