Insulin Resistance Study

NCT00614757 | Suspended DMC

• 2 other identifiers: PKP000300173
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin Resistance; Metabolic Syndrome x

Outcome Measures

Primary Outcomes (1)

• Those patients who are identified to have insulin resistance will be asked to participate in the treatment phase of the study

  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

  2 years

Study Arms (2)

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

Drug: N-acetylcysteine 20% 4ml; Drug: N-acetylcysteine 20% in 4 ml

Interventions

N-acetylcysteine 20% 4ml DRUG

N-acetylcysteine 20% 4ml

1

N-acetylcysteine 20% in 4 ml DRUG

N-acetylcysteine 20% in 4 ml

1

Eligibility Criteria

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

You may qualify if:

• 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
• Serum Creatinine \<20% ULN
• TSH WNL
• AFP \</= 100

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead

Study Sites (1)

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Prashant K Pandya, DO

  Kansas City VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: May 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

US (1)