Clinical trial NCT03820102: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HCV
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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)

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

Primary outcomes:
measure: SVR12
timeFrame: 12 week after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Laila Abd Elbaky, profesor
role: STUDY_CHAIR
References:
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citation: 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.