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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 : Unknown
Verified February 2019 by Mohamed Hassan Abdelgawad, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Hassan Abdelgawad, Assiut University

Tracking Information
First Submitted Date January 25, 2019
First Posted Date January 29, 2019
Last Update Posted Date February 5, 2019
Estimated Study Start Date March 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 28, 2019)
SVR12 [ Time Frame: 12 week after treatment ]
sustained virological response 12 week after treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs
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
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
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)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population
  1. Full history and clinical evaluation.
  2. Body weight and height
  3. BMI will calculate as weight divided by squared height (kg/m2)
  4. Waist circumference
  5. Blood pressure (mmHg)

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 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:
  • Abdominal Ultrasound
  • Electrocardiogram
Condition HCV
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 28, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Chronic HCV will receive DAAs for treatment

Exclusion Criteria:

  1. Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant
  2. Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human immunodeficiency virus)
  3. Extra-hepatic malignancy except after two years of disease free interval.
  4. Patients with diabetes mellitus.
  5. Patients with Chronic kidney disease.
  6. Pregnancy or in ability to use effective contraception.
  7. Patients with history of using lipid lowering therapy
  8. relapser or failure of previous HCV treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03820102
Other Study ID Numbers IR,VitD in HCV
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mohamed Hassan Abdelgawad, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Chair: Laila Abd Elbaky, profesor Assiut University
PRS Account Assiut University
Verification Date February 2019