ObesityNCT00755742
Lifestyle Intervention Targetting Obesity and Insulin Resistance in Chronic Hepatitis C
A study testing Lifestyle intervention in people with Obesity and Insulin Resistance, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Aug 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese (BMI >/= 30)
- insulin resistant (HOMA-IR >/= 2.1)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T2S8
About this study
Official title: 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.
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.
Read the detailed description
The hepatitis C virus (HCV) chronically infects an estimated 240,000 in Canada and 170 million worldwide. Untreated, CHC is associated with significant long-term clinical consequences including cirrhosis, liver failure and hepatocellular cancer (HCC), and it is the most common indication for liver transplantation in North America. CHC is associated with metabolic manifestations independent of the degree of hepatic fibrosis which include insulin resistance (IR) and type 2 diabetes (T2DM), which have a significantly higher prevalence in CHC compared with the general population. Patients with CHC and T2DM have an increased risk of HCC in addition to morbidity from systemic complications.
Our previous work demonstrates that the prevalence of obesity (BMI ≥30kg/m2) amongst patients with CHC is 28.8%, over twice the prevalence in the Canadian population, and the presence of obesity is independently associated with viremia (positive HCV-RNA). Obesity promotes hepatic fibrosis progression and is independently associated with IR in non-cirrhotic CHC; the prevalence of IR increases with higher BMI in CHC. Insulin resistance can be reversed if viral clearance is achieved; however loss of IR is less likely to occur in the obese even if they have cleared the virus. Obesity and IR are associated with non-response to antiviral therapy. Whilst IR has been improved with the use of metformin in patients with CHC, this was ineffective in increasing rates of response to antiviral treatment. The aims of our study are:
- To evaluate the effect of a three-pronged lifestyle intervention comprising diet, exercise and behavior modification on insulin resistance in obese patients with current and cured chronic hepatitis C.
- To formulate specific recommendations for lifestyle changes to improve insulin resistance and lose weight, thereby reducing the risk of diabetes and other metabolic complications, and potentially enhancing response to antiviral therapy in obese patients with CHC.
- To examine the impact of this intervention on IR, insulin sensitivity and serum adipokine levels for the purpose of investigating the mechanism of insulin resistance in obesity with and without viremia due to chronic hepatitis C infection.
We will utilize a multidisciplinary approach by collaborating with the disciplines of gastroenterology, nutrition, endocrinology, exercise physiology and psychiatry. This prospective study will include 13 non-cirrhotic and 13 cirrhotic, insulin resistant (HOMA-IR ≥2.1) and obese patients (non-Genotype 3, as the latter have marked fatty liver in absence of obesity); as well as 13 non-cirrhotic and 13 cirrhotic, insulin resistant and obese patients with successfully treated CHC (ie now non-viremic) to act as controls. Assessments for measures of IR and obesity (including oral glucose tolerance test to calculate insulin sensitivity index (ISI), serum adipokines, free fatty acids, anthropometry and body composition by abdominal DEXA) will be made. The HOMA-IR (measuring hepatic IR) will be the primary outcome for the experimental maneuver, which will take place over 24 weeks. It will comprise 3 components:
- Diet: participants will be advised on an individually tailored diet of low glycemic foods, low total fat (but rich in omega-3 fatty acid) and high fiber aimed at both weight loss and improvement of insulin resistance.
- Exercise: physical activity will be measured with the use of a personal pedometer, and participants given a step target of 10000 steps per day, or an increment of 3000 steps per day from their baseline activity (whichever is greater).
- Behavior Modification: the change in diet and physical activity will be facilitated by a 12-week face-to face program followed by a 12-week telephone program based on the principals of motivational interviewing and behavior theory.
The intercurrence of obesity and IR in subjects chronically infected with hepatitis C exacerbates their poor current and future health status. As the pathophysiology of IR in patients with CHC may differ from those who are obese but no longer infected, we will quantify the benefits of the lifestyle intervention in these two patient groups as gauged by fall in HOMA-IR score and improvement in ISI. Our long-term goals are to improve the outcome of antiviral therapy and reduce the burden of CHC, obesity and type 2 diabetes related morbidity. This we hope to achieve through gaining a better understanding of the mechanisms involved in the development of IR in the obese with and without current CHC.
- Conditions
- Obesity, Insulin Resistance, Metabolic Syndrome, Hepatitis C
- Being tested
- Lifestyle intervention
- Keywords
- obesity, insulin resistance, metabolic syndrome, hepatitis C, adipokine, TNF, leptin, adiponectin, fatigue, mood, depression, exercise, diet, counseling, behavior modification
- Medical subject headings
- Obesity, Insulin Resistance, Metabolic Syndrome, Hepatitis C, Fatigue, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionOther
The 3-pronged lifestyle intervention is designed to deliver a period of intensive contact (week 0-12) and less-intensive contact (weeks 12-24):
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Viremic / Non-cirrhotic | Experimental | 13 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. Receives: Other: Lifestyle intervention |
| Group 2 - Non-viremic / Non-cirrhotic | Active comparator | 13 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. Receives: Other: Lifestyle intervention |
| Group 3 - Viremic / Cirrhotic | Experimental | 13 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. Receives: Other: Lifestyle intervention |
| Group 4 - Non-viremic / Cirrhotic | Active comparator | 13 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 Receives: Other: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR
Measured: 12 and 24 weeks
Secondary outcomes (15)
TNF-alpha
Measured: 12 and 24 weeks
leptin
Measured: 12 and 24 weeks
adiponectin
Measured: 12 and 24 weeks
fatigue score
Measured: 12 and 24 weeks
mood score
Measured: 12 and 24 weeks
cholesterol
Measured: 12 and 24 weeks
triglycerides
Measured: 12 and 24 weeks
HDL-cholesterol
Measured: 12 and 24 weeks
LDL-cholesterol
Measured: 12 and 24 weeks
RBC fatty acid composition
Measured: 12 and 24 weeks
BMI
Measured: 12 and 24 weeks
Waist circumference
Measured: 12 and 24 weeks
Metabolic Syndrome
Measured: 12 and 24 weeks
CLDQ (Chronic Liver Disease Questionnaire)
Measured: 12 and 24 weeks
Liver and Peripheral Insulin Resistance
Scores derived from glucose and insulin levels in the oral glucose tolerance test (OGTT)
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Venessa Pattullo, University Health Network, Toronto
- Investigators
- Elizabeth J Heathcote, MD FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755742
- Sponsor's protocol ID
- 08-0545-AE
- Status last verified
- Sep 2011
- First submitted
- 17 Sep 2008
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00755742
- Acronym / sponsor ID
- 08-0545-AE
- Conditions
- Obesity, Insulin Resistance, Metabolic Syndrome, Hepatitis C
- Keywords
- obesity, insulin resistance, metabolic syndrome, hepatitis C, adipokine, TNF, leptin, adiponectin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Sep 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.
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.
Detailed description
The hepatitis C virus (HCV) chronically infects an estimated 240,000 in Canada and 170 million worldwide. Untreated, CHC is associated with significant long-term clinical consequences including cirrhosis, liver failure and hepatocellular cancer (HCC), and it is the most common indication for liver transplantation in North America. CHC is associated with metabolic manifestations independent of the degree of hepatic fibrosis which include insulin resistance (IR) and type 2 diabetes (T2DM), which have a significantly higher prevalence in CHC compared with the general population. Patients with CHC and T2DM have an increased risk of HCC in addition to morbidity from systemic complications.
Our previous work demonstrates that the prevalence of obesity (BMI ≥30kg/m2) amongst patients with CHC is 28.8%, over twice the prevalence in the Canadian population, and the presence of obesity is independently associated with viremia (positive HCV-RNA). Obesity promotes hepatic fibrosis progression and is independently associated with IR in non-cirrhotic CHC; the prevalence of IR increases with higher BMI in CHC. Insulin resistance can be reversed if viral clearance is achieved; however loss of IR is less likely to occur in the obese even if they have cleared the virus. Obesity and IR are associated with non-response to antiviral therapy. Whilst IR has been improved with the use of metformin in patients with CHC, this was ineffective in increasing rates of response to antiviral treatment. The aims of our study are:
- To evaluate the effect of a three-pronged lifestyle intervention comprising diet, exercise and behavior modification on insulin resistance in obese patients with current and cured chronic hepatitis C.
- To formulate specific recommendations for lifestyle changes to improve insulin resistance and lose weight, thereby reducing the risk of diabetes and other metabolic complications, and potentially enhancing response to antiviral therapy in obese patients with CHC.
- To examine the impact of this intervention on IR, insulin sensitivity and serum adipokine levels for the purpose of investigating the mechanism of insulin resistance in obesity with and without viremia due to chronic hepatitis C infection.
We will utilize a multidisciplinary approach by collaborating with the disciplines of gastroenterology, nutrition, endocrinology, exercise physiology and psychiatry. This prospective study will include 13 non-cirrhotic and 13 cirrhotic, insulin resistant (HOMA-IR ≥2.1) and obese patients (non-Genotype 3, as the latter have marked fatty liver in absence of obesity); as well as 13 non-cirrhotic and 13 cirrhotic, insulin resistant and obese patients with successfully treated CHC (ie now non-viremic) to act as controls. Assessments for measures of IR and obesity (including oral glucose tolerance test to calculate insulin sensitivity index (ISI), serum adipokines, free fatty acids, anthropometry and body composition by abdominal DEXA) will be made. The HOMA-IR (measuring hepatic IR) will be the primary outcome for the experimental maneuver, which will take place over 24 weeks. It will comprise 3 components:
- Diet: participants will be advised on an individually tailored diet of low glycemic foods, low total fat (but rich in omega-3 fatty acid) and high fiber aimed at both weight loss and improvement of insulin resistance.
- Exercise: physical activity will be measured with the use of a personal pedometer, and participants given a step target of 10000 steps per day, or an increment of 3000 steps per day from their baseline activity (whichever is greater).
- Behavior Modification: the change in diet and physical activity will be facilitated by a 12-week face-to face program followed by a 12-week telephone program based on the principals of motivational interviewing and behavior theory.
The intercurrence of obesity and IR in subjects chronically infected with hepatitis C exacerbates their poor current and future health status. As the pathophysiology of IR in patients with CHC may differ from those who are obese but no longer infected, we will quantify the benefits of the lifestyle intervention in these two patient groups as gauged by fall in HOMA-IR score and improvement in ISI. Our long-term goals are to improve the outcome of antiviral therapy and reduce the burden of CHC, obesity and type 2 diabetes related morbidity. This we hope to achieve through gaining a better understanding of the mechanisms involved in the development of IR in the obese with and without current CHC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Viremic / Non-cirrhotic | Experimental | Other: Lifestyle intervention13 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 comparator | Other: Lifestyle intervention13 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 | Experimental | Other: Lifestyle intervention13 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 comparator | Other: Lifestyle intervention13 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- obese (BMI >/= 30)
- insulin resistant (HOMA-IR >/= 2.1)
Key exclusion criteria (14 listed)
- 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).
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 |
|---|---|---|
| Lifestyle interventionThe 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. | Other | Group 1 - Viremic / Non-cirrhotic, Group 2 - Non-viremic / Non-cirrhotic, Group 3 - Viremic / Cirrhotic, Group 4 - Non-viremic / Cirrhotic |
Primary outcome
HOMA-IR
Time frame: 12 and 24 weeks
15 secondary outcomes
TNF-alpha
Time frame: 12 and 24 weeks
leptin
Time frame: 12 and 24 weeks
adiponectin
Time frame: 12 and 24 weeks
fatigue score
Time frame: 12 and 24 weeks
mood score
Time frame: 12 and 24 weeks
cholesterol
Time frame: 12 and 24 weeks
triglycerides
Time frame: 12 and 24 weeks
HDL-cholesterol
Time frame: 12 and 24 weeks
LDL-cholesterol
Time frame: 12 and 24 weeks
RBC fatty acid composition
Time frame: 12 and 24 weeks
BMI
Time frame: 12 and 24 weeks
Waist circumference
Time frame: 12 and 24 weeks
Metabolic Syndrome
Time frame: 12 and 24 weeks
CLDQ (Chronic Liver Disease Questionnaire)
Time frame: 12 and 24 weeks
Liver and Peripheral Insulin Resistance
Time frame: 12 and 24 weeks
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 22 Sep 2011.
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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.
Elizabeth J Heathcote, MD FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Obesity and Insulin Resistance, run by University Health Network, Toronto at 1 site in Canada.
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 14 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 22 Sep 2011. 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 Canada. 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?
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?
HOMA-IR (time frame: 12 and 24 weeks). 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 22 Sep 2011.