Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs
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|ClinicalTrials.gov Identifier: NCT03820102|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : February 5, 2019
- 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
- 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
|Condition or disease|
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
Patients presenting in this study will be subjected to the following:
- Full history and clinical evaluation.
- Body weight (kg) and height (m).
- BMI will calculate as weight divided by squared height (kg/m2).
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||October 2019|
Vit D deficiency
Chronic HCV patients with vitamin D deficiency Sustained virological response after treatment
Normal Vit D
Chronic HCV patients with normal vitamin D level Sustained virological response after treatment
- SVR12 [ Time Frame: 12 week after treatment ]sustained virological response 12 week after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820102
|Contact: Mohamed H Abdelgawad, email@example.com|
|Study Chair:||Laila Abd Elbaky, profesor||Assiut University|