Lifestyle Intervention Targetting Obesity and Insulin Resistance in Chronic Hepatitis C
Evaluation of the Impact of a Combined Program of Diet, Exercise and Behavior Modification on the Insulin Resistance and Adipokine Profile in Obese Patients With Current and Cured Chronic Hepatitis C.
1 other identifier
interventional
24
1 country
1
Brief Summary
Chronic hepatitis C (CHC) infection affects approximately 1 in 100 Canadians. Untreated, CHC has significant long-term consequences including cirrhosis, liver cancer and liver failure. CHC is intrinsically linked to both obesity and insulin resistance (IR) or "pre-diabetes", their co-existence worsens overall health outcomes. We have demonstrated that obesity (BMI ≥30kg/m2) is over twice as common amongst patients with CHC (28.8%) compared with the general Canadian population. Obesity superimposed on CHC reduces the success of antiviral treatment and promotes liver scarring (hepatic fibrosis), fatty liver (steatosis) and increases the risk of liver cancer. Both CHC and obesity contribute to IR putting these patients at risk of type 2 diabetes. IR, like obesity in CHC, reduces antiviral success rates. We have shown that diabetics are at higher risk of developing liver cancer compared with non-diabetics. It is therefore timely to address lifestyle modification to delay the onset of diabetes. We will examine the impact of a multidisciplinary lifestyle program on the insulin resistance in 52 obese "pre-diabetic" patients with current or past CHC. The 24 week program comprises an individualized nutritional and exercise plan supported by behavior modification counseling. Through gaining a better understanding of links between obesity, insulin resistance and hepatitis C infection we hope to delay the onset of diabetes and reduce the likelihood of all their untoward effects on the liver.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Nov 2008
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedSeptember 22, 2011
September 1, 2011
2.2 years
September 17, 2008
September 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HOMA-IR
12 and 24 weeks
Secondary Outcomes (15)
TNF-alpha
12 and 24 weeks
leptin
12 and 24 weeks
adiponectin
12 and 24 weeks
fatigue score
12 and 24 weeks
mood score
12 and 24 weeks
- +10 more secondary outcomes
Study Arms (4)
Group 1 - Viremic / Non-cirrhotic
EXPERIMENTAL13 obese and insulin resistant, non-cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with chronic hepatitis C (HCV RNA positive) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who are naive to antiviral therapy, relapsed or not responded to antiviral therapy.
Group 2 - Non-viremic / Non-cirrhotic
ACTIVE COMPARATOR13 obese and insulin resistant, non-cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with cured chronic hepatitis C (HCV RNA negative) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who have cleared hepatitis C virus with previous antiviral therapy.
Group 3 - Viremic / Cirrhotic
EXPERIMENTAL13 obese and insulin resistant, cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with chronic hepatitis C (HCV RNA positive) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who are naive to antiviral therapy, relapsed or not responded to antiviral therapy.
Group 4 - Non-viremic / Cirrhotic
ACTIVE COMPARATOR13 obese and insulin resistant, cirrhotic, non-diabetic (by fasting glucose), non-genotype 3 patients with cured chronic hepatitis C (HCV RNA negative) will undergo 24 week lifestyle intervention comprising diet, physical activity (monitored by pedometers) in combination with behavior modification counseling. This arm includes patients who have cleared hepatitis C virus with previous antiviral therapy
Interventions
The 3-pronged lifestyle intervention is designed to deliver a period of intensive contact (week 0-12) and less-intensive contact (weeks 12-24): i) Behavior Modification Counseling: The principles of motivational enhancement and cognitive-behavior therapy (MET/CBT) will be utilized at each visit and telephone contact to provide individually tailored counseling. The goal is to enhance internal motivation and facilitate changes in lifestyle that are adaptable to each participant's usual habits. ii) Physical activity target: increment in activity of at least 3000 steps/day above the baseline, or total activity of 10,000 steps/day (whichever is greater). iii) Dietary assessment and nutritional plan: A diet plan designed to both lose weight and improve insulin resistance will be provided.
Eligibility Criteria
You may qualify if:
- obese (BMI \>/= 30)
- insulin resistant (HOMA-IR \>/= 2.1)
You may not qualify if:
- Genotype 3 patients
- Women with ongoing pregnancy or who are breast-feeding
- Patients with any other other underlying liver disease (viral, alcoholic, druginduced, autoimmune, metabolic, genetic).
- Patients currently on antiviral therapy, or who have ceased therapy within 6 months of recruitment to the study.
- Patients with other causes for insulin resistance e.g., excess counter-regulatory hormones: glucocorticoids, catecholamines, growth hormone, polycystic ovary syndrome).
- Patients on steroids or other drug that affects insulin resistance, which are unable to be stopped for 3 days prior to IR testing.
- Patients with overt diabetes (based on results of fasting plasma glucose) will be excluded from participation as we are focusing on insulin resistance in the absence of diabetes.
- Conditions which preclude a sudden increase in physical activity:
- History or other evidence of chronic pulmonary disease associated with functional limitation.
- History of severe cardiac disease (e.g., NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases).
- Unable to 10000 steps/day eg physical disability, morbid obesity.
- Evidence of ongoing substance use (including alcohol consumption \>20g/day for men and \>10g/day for women) within one year of study recruitment.
- Poor veins (inadequate venous access)
- Inability or unwillingness to provide informed consent or abide by study requirements eg severe psychiatric illness, lives remotely, time commitment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T2S8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth J Heathcote, MD FRCPC
University Health Network, Toronto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Collaborator
Study Record Dates
First Submitted
September 17, 2008
First Posted
September 19, 2008
Study Start
November 1, 2008
Primary Completion
January 1, 2011
Study Completion
August 1, 2011
Last Updated
September 22, 2011
Record last verified: 2011-09