Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs

NCT03820102 | Unknown

• 1 other identifier: IR,VitD in HCV
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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

Conditions

HCV

Outcome Measures

Primary Outcomes (1)

• SVR12

  sustained virological response 12 week after treatment

  12 week after treatment

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Chronic HCV will receive DAAs for treatment

You may not qualify if:

• Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant
• Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human immunodeficiency virus)
• Extra-hepatic malignancy except after two years of disease free interval.
• Patients with diabetes mellitus.
• Patients with Chronic kidney disease.
• Pregnancy or in ability to use effective contraception.
• Patients with history of using lipid lowering therapy
• relapser or failure of previous HCV treatment

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Janovy J Jr. Problems in the comparative physiology of some trypanosomatid flagellates. Acta Trop. 1977 Jun;34(2):177-84.

  PMID: 19960 RESULT

• Selhub J, Rosenberg IH. Demonstration of high-affinity folate binding activity associated with the brush border membranes of rat kidney. Proc Natl Acad Sci U S A. 1978 Jul;75(7):3090-3. doi: 10.1073/pnas.75.7.3090.

  PMID: 28521 RESULT

• Ramachandran N, Colman RF. Evidence for a critical glutamyl and an aspartyl residue in the function of pig heart diphosphopyridine nucleotide dependent isocitrate dehydrogenase. Biochemistry. 1977 Apr 19;16(8):1564-73. doi: 10.1021/bi00627a006.

  PMID: 15585 RESULT

Study Officials

• Laila Abd Elbaky, profesor

  Assiut University

  STUDY CHAIR

Central Study Contacts

Mohamed H Abdelgawad, specialist

CONTACT

01008778754; d_m_h_80@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologest and hepatologest, doctor in Assiut Police Hospital

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share