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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

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

Condition or disease
HCV

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)

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
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



Primary Outcome Measures :
  1. SVR12 [ Time Frame: 12 week after treatment ]
    sustained virological response 12 week after treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Mohamed H Abdelgawad, specialist 01008778754 d_m_h_80@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Laila Abd Elbaky, profesor Assiut University
Publications of Results:
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Responsible Party: Mohamed Hassan Abdelgawad, Gastroenterologest and hepatologest, doctor in Assiut Police Hospital, Assiut University
ClinicalTrials.gov Identifier: NCT03820102    
Other Study ID Numbers: IR,VitD in HCV
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection