Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT03820102
Status:
UNKNOWN
Last Update Posted:
2019-02-05
First Post:
2019-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With Hepatitis C Viral Infection Treated by Direct Acting Antiviral Drugs
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
NOT_YET_RECRUITING
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:
1. Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents
2. The assessment of serum vitamin D levels in HCV infected patients and predictive value of pre-treatment serum vitamin D level for achieving sustained virological response at 12 weeks post-treatment
2. The assessment of serum vitamin D levels in HCV infected patients and predictive value of pre-treatment serum vitamin D level for achieving sustained virological response at 12 weeks post-treatment
Detailed Description:
Patients and methods:
This cross-sectional study will include 100patients of chronic HCV infection who attend El Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease.
Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm sustained virological response
Method:
Patients presenting in this study will be subjected to the following:
1. Full history and clinical evaluation.
2. Body weight (kg) and height (m).
3. BMI will calculate as weight divided by squared height (kg/m2).
4. Waist circumference will measured at a level midway between the lowest rib and the iliac crest, and the hip circumference at the level of the great trochanters, with the legs close together.
5. Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest and taken an average.
Laboratory investigations will include:
* Complete blood count (CBC)
* Liver function test
* HCV Ab and HCV RNA by PCR
* HBs Ag
* Alpha fetoprotein
* Lipid profile
* Serum urea and creatinine
* Fasting blood sugar (FBG)and Serum fasting insulin level
* Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) ----------------------------------------------------------------- 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)
* Vitamin D level:
Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level \< 20 ng/mL, vitaminD insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30 ng/mL (Holick MF et al.,2011)
* Abdominal Ultrasound
* Electrocardiogram (ECG)
This cross-sectional study will include 100patients of chronic HCV infection who attend El Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease.
Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm sustained virological response
Method:
Patients presenting in this study will be subjected to the following:
1. Full history and clinical evaluation.
2. Body weight (kg) and height (m).
3. BMI will calculate as weight divided by squared height (kg/m2).
4. Waist circumference will measured at a level midway between the lowest rib and the iliac crest, and the hip circumference at the level of the great trochanters, with the legs close together.
5. Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest and taken an average.
Laboratory investigations will include:
* Complete blood count (CBC)
* Liver function test
* HCV Ab and HCV RNA by PCR
* HBs Ag
* Alpha fetoprotein
* Lipid profile
* Serum urea and creatinine
* Fasting blood sugar (FBG)and Serum fasting insulin level
* Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) ----------------------------------------------------------------- 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)
* Vitamin D level:
Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level \< 20 ng/mL, vitaminD insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30 ng/mL (Holick MF et al.,2011)
* Abdominal Ultrasound
* Electrocardiogram (ECG)
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?: