Insulin ResistancePhase 4NCT04457050

Effect of Hepatitis C Clearance on Insulin Resistance

A Phase 4 study testing Sofosbuvir 400 milligram, Daclatasvir 60 milligram and Ribavirin 400 milligram in people with Insulin Resistance and Hepatitis C, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Chronic hepatitis C infection has been linked to insulin resistance, which is the essential component of metabolic syndrome and type 2 diabetes mellitus. Resistin; an adipokine, has been demonstrated to stimulate the secretion of several inflammatory factors known to play a role in the induction of insulin resistance. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Insulin Resistance, Hepatitis C
What is being tested?: Sofosbuvir 400 milligram, Daclatasvir 60 milligram and Ribavirin 400 milligram
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteEgypt
Study dates: 30 Oct 2017to 30 Dec 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Hepatitis C treatment-naïve;
Non-diabetic patients.

Who cannot join

Seropositivity for hepatitis B virus infection;
Diabetes mellitus;
Bbody mass index ≥ 30 Kg/M*2;
History of alcohol consumption;
Endocrinopathies that may affect the glycemic homeostasis;
Other known causes of chronic liver disease; Hepatic decompensation [defined as history of gastrointestinal bleeding (melena and /or hematemesis), jaundice, coagulopathy, hepatic encephalopathy, and/or ascites]; bleeding diathesis;

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Connective tissue diseases;
Autoimmune diseases;
Cardiac, respiratory or renal disease.
Patient receiving immuno-modulatory therapy or drugs that affect the blood glucose levels such as steroids or beta-blockers.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Medicine
Alexandria, 21521

Other trials in Egypt

About this study

Official title: Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs.

Read the detailed description

the link between hepatitis C infection and insulin resistance has been established. Insuli resistance has been linked to poor response to interferon based therapy. recently, direct acting antiviral drugs are approved for hepatitis C elimination with high potency and safety. The aim of the study is to: 1. Determine the prevalence of insulin resistance among non-diabetic patients with chronic HCV infection. 2. Explore the impact of treatment with DAAs on insulin resistance among chronic HCV infected patients. 3. Investigate the role of insulin resistance as a potential prognostic factor for the response to DAAs. 4. Explore the utility of resistin as a potential biomarker IR among HCV infected patients.

Conditions: Insulin Resistance, Hepatitis C
Being tested: Sofosbuvir 400 milligram, Daclatasvir 60 milligram, Ribavirin 400 milligram, Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab
Medical subject headings: Insulin Resistance, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sofosbuvir 400 milligramDrug
Also called Soflanork 400 milligram, Gratisovir 400 milligram
single daily dose of 400 milligrams
Daclatasvir 60 milligramDrug
Also called Daklanork 60 milligram, Daktavira 60 milligram
single daily dose of 60 milligrams for 12 weeks
Ribavirin 400 milligramDrug
Also called Riba 400 milligram
weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks
Ledipasvir 90milligram/Sofosbuvir 400 milligram TabDrug
Also called HARVONI, Soflanork plus
single daily dose for 12 weeks

Study groups in NCT04457050
Study group	Role	What they receive
Non-Diabetic Hepatitis C infected patients	Experimental	1. clinical examination, 2. measurement of weight (Kg), height (meter), and waist circumference (cm). 3. Calculation of the body mass index. 4. Ultrasound abdominal examination. 5. Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included. 6. Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin). 7. Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment. 8. measurement of serum levels of resistin before and at 12 weeks after treatment. Receives: Drug: Sofosbuvir 400 milligram; Drug: Daclatasvir 60 milligram; Drug: Ribavirin 400 milligram; Drug: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the insulin resistance before and after hepatitis C clearance
Assess the change in the value of Homeostatic Model Assessment for Insulin resistance (Homeostatic Model Assessment for Insulin Resistance) after hepatitis C treatment by calculating the HOMA-IR for all patients at baseline and the re-calculation at 12 weeks after viral clearance to clarify the impact of hepatitis C treatment by direct antiviral drugs on insulin sensitivity.
Measured: at baseline and 12 weeks after sustained virologic response

Secondary outcomes (2)

Prevalence of insulin resistance among hepatitis C patients
Prevalence of insulin resistance among hepatitis C patients
Measured: at baseline
Sustained virologic response
Sustained virologic response
Measured: at 12 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201730 Dec 2019

First posted7 Jul 2020
Study start30 Oct 2017
Primary completion1 Nov 2019
Study completion30 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Insulin ResistanceStudies of the same condition, open and under way.
More trials run by Alexandria UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04457050
Sponsor's protocol ID: 020966
Status last verified: Jun 2020
First submitted: 29 Jun 2020
Last updated: 7 Jul 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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All Insulin Resistance trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Insulin Resistance and Resistin In Non-Diabetic Patients With Chronic Hepatitis C Before and After Direct-Acting Antiviral Drugs.
ClinicalTrials.gov ID: NCT04457050
Acronym / sponsor ID: 020966
Conditions: Insulin Resistance, Hepatitis C
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 30 Oct 2017 (actual)
Primary completion: 1 Nov 2019 (actual)
Study completion: 30 Dec 2019 (actual)
First posted: 7 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Non-Diabetic Hepatitis C infected patients	Experimental	Drug: Sofosbuvir 400 milligram, Drug: Daclatasvir 60 milligram, Drug: Ribavirin 400 milligram, Drug: Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab1. clinical examination, 2. measurement of weight (Kg), height (meter), and waist circumference (cm). 3. Calculation of the body mass index. 4. Ultrasound abdominal examination. 5. Laboratory Investigations including Complete blood count, Serum aspartate and alanine aminotransferases, serum albumin, serum bilirubin, serum gamma-glutamyl transpeptidase, and international normalization ratio. HCV-RNA quantification before treatment and 12 weeks after the end of therapy.. Serum lipid profile, fasting and post-prandial blood sugar, glycated hemoglobin A1c also included. 6. Treatment of all patients with the available generic direct antivirals in Egypt (sofosbuvir/ledipasvir ± ribavirin or sofosbuvir plus daclatasvir ± ribavirin). 7. Evaluation of insulin resistance using the homeostasis model assessment of insulin resistance before and 12 weeks after end of treatment. 8. measurement of serum levels of resistin before and at 12 weeks after treatment.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Hepatitis C treatment-naïve;
Non-diabetic patients.

Key exclusion criteria (10 listed)

Seropositivity for hepatitis B virus infection;
Diabetes mellitus;
Bbody mass index ≥ 30 Kg/M*2;
History of alcohol consumption;
Endocrinopathies that may affect the glycemic homeostasis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sofosbuvir 400 milligramAlso: Soflanork 400 milligram, Gratisovir 400 milligramsingle daily dose of 400 milligrams	Drug	Non-Diabetic Hepatitis C infected patients
Daclatasvir 60 milligramAlso: Daklanork 60 milligram, Daktavira 60 milligramsingle daily dose of 60 milligrams for 12 weeks	Drug	Non-Diabetic Hepatitis C infected patients
Ribavirin 400 milligramAlso: Riba 400 milligramweight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks	Drug	Non-Diabetic Hepatitis C infected patients
Ledipasvir 90milligram/Sofosbuvir 400 milligram TabAlso: HARVONI, Soflanork plussingle daily dose for 12 weeks	Drug	Non-Diabetic Hepatitis C infected patients

Primary outcome

Change in the insulin resistance before and after hepatitis C clearance
Time frame: at baseline and 12 weeks after sustained virologic response
Assess the change in the value of Homeostatic Model Assessment for Insulin resistance (Homeostatic Model Assessment for Insulin Resistance) after hepatitis C treatment by calculating the HOMA-IR for all patients at baseline and the re-calculation at 12 weeks after viral clearance to clarify the impact of hepatitis C treatment by direct antiviral drugs on insulin sensitivity.

2 secondary outcomes

Prevalence of insulin resistance among hepatitis C patients
Time frame: at baseline
Sustained virologic response
Time frame: at 12 weeks after treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Individual participant dataSharing planned: No

Related trials for Insulin Resistance

Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the insulin resistance before and after hepatitis C clearance (time frame: at baseline and 12 weeks after sustained virologic response). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04457050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.