Insulin ResistanceIRNCT00614757
Insulin Resistance Study
A study testing N-acetylcysteine 20% 4ml and N-acetylcysteine 20% in 4 ml in people with Insulin Resistance and Metabolic Syndrome x, run by Midwest Biomedical Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how often patients with hepatitis C infection have abnormalities of sugar and fat utilization. Additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Metabolic Syndrome x
- What is being tested?
- N-acetylcysteine 20% 4ml and N-acetylcysteine 20% in 4 ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Dec 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give written consent
- HCV RNA PCR positive for 6 months
- Normal Hgb, WBC,Neutrophils
- Platelets of >/= 65,000
- Direct Bili, within 20% ULN
- Albumin >3
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- Serum Creatinine <20% ULN
- TSH WNL
- AFP </= 100
Who cannot join
- Women who are pregnant or breast-feeding
- No Thiazolidinedione, Metformin,unless required for the treatment of type II DM
- Hepatitis C of non-genotype 1,2,3
- Any other cause for liver disease other than chronic hepatitis C
- Hemoglobinopathies
- Evidence of advanced liver disease
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- Previous organ transplant
- Severe psychiatric disorder
- Significant cardiovascular dysfunction within the past 12 months
- Poorly controlled diabetes mellitus
- Immunologically mediated disease
- Any medical condition requiring chronic systemic administration of steroids
- Evidence of an active or suspected cancer
- Substance abuse at the time of the study
- Known HIV
- Irritability or unwillingness to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City VA Medical Center
Kansas City, Missouri, 64128
About this study
Official title: The Prevalence of Insulin Resistance and the Potential Modulation of Insulin Resistance by N-acetylcysteine (NAC) in Patients Chronically Infected by the Hepatitis C Virus
The purpose of this study is to evaluate how often patients with hepatitis C infection have abnormalities of sugar and fat utilization. Additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight.
- Conditions
- Insulin Resistance, Metabolic Syndrome x
- Being tested
- N-acetylcysteine 20% 4ml, N-acetylcysteine 20% in 4 ml
- Medical subject headings
- Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteine 20% 4mlDrug
N-acetylcysteine 20% 4ml
N-acetylcysteine 20% in 4 mlDrug
N-acetylcysteine 20% in 4 ml
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | One half of the patients will take not medication for 30 days and then have labs redrawn |
| 1 | Experimental | one half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days Receives: Drug: N-acetylcysteine 20% 4ml; Drug: N-acetylcysteine 20% in 4 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study
Measured: 2 years
Secondary outcomes (1)
One half of patients with insulin resistance will undergo 30 day treatment with N-acetylcysteine to see if we can measure an improvement in fasting insulin and glucose levels
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMay 2005
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Pandya, Kansas City Veteran Affairs Medical Center
- Investigators
- Prashant K Pandya, DO, Principal investigator, Kansas City VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614757
- Sponsor's protocol ID
- PKP0003
- Other IDs
- 00173
- Acronym
- IR
- Status last verified
- Oct 2012
- First submitted
- 31 Jan 2008
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Insulin Resistance and the Potential Modulation of Insulin Resistance by N-acetylcysteine (NAC) in Patients Chronically Infected by the Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT00614757
- Acronym / sponsor ID
- IR / PKP0003
- Conditions
- Insulin Resistance, Metabolic Syndrome x
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 13 Feb 2008 (estimated)
- 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.
The purpose of this study is to evaluate how often patients with hepatitis C infection have abnormalities of sugar and fat utilization. Additionally we would like to find out if these abnormalities of sugar and fat utilization are common in other liver diseases, or related to being overweight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –One half of the patients will take not medication for 30 days and then have labs redrawn |
| 1 | Experimental | Drug: N-acetylcysteine 20% 4ml, Drug: N-acetylcysteine 20% in 4 mlone half of the patients with insulin resistance will take 4ml of 20% N-acetylcysteine BID for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to give written consent
- HCV RNA PCR positive for 6 months
- Normal Hgb, WBC,Neutrophils
- Platelets of >/= 65,000
- Direct Bili, within 20% ULN
Key exclusion criteria (16 listed)
- Women who are pregnant or breast-feeding
- No Thiazolidinedione, Metformin,unless required for the treatment of type II DM
- Hepatitis C of non-genotype 1,2,3
- Any other cause for liver disease other than chronic hepatitis C
- Hemoglobinopathies
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 |
|---|---|---|
| N-acetylcysteine 20% 4mlN-acetylcysteine 20% 4ml | Drug | 1 |
| N-acetylcysteine 20% in 4 mlN-acetylcysteine 20% in 4 ml | Drug | 1 |
Primary outcome
Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study
Time frame: 2 years
1 secondary outcome
One half of patients with insulin resistance will undergo 30 day treatment with N-acetylcysteine to see if we can measure an improvement in fasting insulin and glucose levels
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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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.
Prashant K Pandya, DO principal investigator
Kansas City VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine 20% 4ml and N-acetylcysteine 20% in 4 ml in people with Insulin Resistance and Metabolic Syndrome x, run by Midwest Biomedical Research at 1 site in United States.
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 9 inclusion and 16 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: paused, as of the sponsor's last update on 26 Oct 2012. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
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?
Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2012.