Cardiovascular DiseaseNCT00877513
Insulin Resistance in Smokers Undergoing Smoking Cessation
A study testing Smoking cessation in people with Cardiovascular Disease and Insulin Resistance, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
Cigarette smoking increases CVD risk and worsens insulin resistance, but also contributes to weight loss; smoking cessation reduces CVD risk and improves insulin sensitivity, but also contributes to weight gain. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Cardiovascular Disease, Insulin Resistance
- What is being tested?
- Smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25 to 70 inclusive; any ethnicity
- Cigarette smoking for at least 3 years, at a rate of at least 1 but not more than 2 packs per day
- BMI 19 kg/m2 or greater and 40 kg/m2 or less
- Willing to enter, and be able to comply with the instructions and scheduled follow-up of a smoking cessation program
Who cannot join
- Any physical disabilities that prevent the subject from participating in the study, as determined by the investigators
- History of CVD (ventricular arrhythmias, atrial arrhythmias with a history of hemodynamic instability, unstable angina, myocardial infarction, invasive coronary revascularization, or any hospitalization for CVD within the last 3 years, NYHA Class III or IV CHF)
- Current abuse of illicit drugs or heavy ethanol use
- History or baseline laboratory evidence of diabetes mellitus
- History of chronic obstructive pulmonary disease (COPD)
- BMI < 19 or > 40 kg/m2
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- Subjects not following a regular diet and lifestyle pattern (e.g, homeless)
- Uncontrolled hypertension (BP 170 mmHg or greater systolic or 110 mmHg or greater diastolic)
- Fasting triglycerides 700 mg/dL or greater, or LDL-cholesterol 200 mg/dL or greater
- History of chronic renal or liver disease (hepatic transaminase elevations > 3 times the upper limit of the normal range; creatinine > 1.5 mg/L), malignancies not currently in remission, gastrointestinal disorders that interfere with nutrition; history of malnutrition, chronic infections (including HIV), or recent (within 30 days) surgeries or hospitalizations
- Concurrent use of medications that may alter metabolic parameters (including metformin, sulfonylurea agents, thiazolidinediones, weight loss agents, androgens or systemic glucocorticoids); lipid-lowering agents and oral contraceptives will be permitted as long as formulations, dosages and adherence remain unchanged throughout the course of the study. Oral contraceptives that are started during the course of the study will require the subject to be withdrawn from the study
- Perimenopausal women experiencing irregular menses, because of changing metabolic status during the perimenopause; these patients may be included if menses have ceased for at least 6 months
- Women who are pregnant, seeking to become pregnant in the next 6 months, or who are breastfeeding
- Any history of depression, suicidality, or any contraindications to bupropion (history of seizures, anorexia or bulimia)
- Current use of nicotine replacement products (gum or patch)
- Any other factors that, in the opinion of the investigators, may interfere with the safe conduct, successful completion, or data integrity of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University of Medicine and Science
Los Angeles, California, 90059
About this study
Cigarette smoking increases CVD risk and worsens insulin resistance, but also contributes to weight loss; smoking cessation reduces CVD risk and improves insulin sensitivity, but also contributes to weight gain. The mechanisms that underlie these metabolic changes of cigarette smoking and smoking cessation on insulin resistance, body composition, and fat distribution are poorly understood.
Read the detailed description
This study is a prospective, open cohort study of smokers who undergo a smoking cessation program, and who subsequently may or may not resume smoking spontaneously. Eligible subjects will be characterized at baseline with respect to their metabolic and CVD risk profiles, body fat composition and distribution. Subjects will then undergo an intensive 8-week smoking cessation program using bupropion plus cognitive behavioral counseling. Those who successfully abstain will be reassessed. Since most individuals who quit smoking will naturally resume smoking again over time, subjects will be assessed again after an additional 4 months of follow-up when a subset of subjects will be expected to have naturally resumed smoking.
- Conditions
- Cardiovascular Disease, Insulin Resistance
- Being tested
- Smoking cessation
- Keywords
- Smoking, Insulin resistance, Metabolic syndrome, Body fat distribution, Cigarette smoking
- Medical subject headings
- Cardiovascular Diseases, Insulin Resistance, Smoking, Metabolic Syndrome, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationBehavioural
Smoking cessation program over 8 weeks, consisting of cognitive behavioral counseling every 2 weeks along with adjunctive use of bupropion
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Cigarette smokers wishing to quit Receives: Behavioral: Smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity by euglycemic hyperinsulinemic clamp
Measured: 8 weeks, 6 months
Secondary outcomes (21)
Body mass index
Measured: 8 weeks, 4 months, 6 months
Body composition
Measured: 8 weeks, 4 months, 6 months
Body fat distribution
Measured: 8 weeks, 4 months, 6 months
Blood pressure
Measured: 8 weeks, 4 months, 6 months
Fasting lipid profile
Measured: 8 weeks, 4 months, 6 months
Apolipoproteins
Measured: 8 weeks, 4 months, 6 months
Fasting plasma glucose
Measured: 8 weeks, 4 months, 6 months
HOMA-IR index
Measured: 8 weeks, 4 months, 6 months
Adipokines
Measured: 8 weeks, 4 months, 6 months
Highly-sensitive C-reactive protein
Measured: 8 weeks, 4 months, 6 months
Morning cortisol
Measured: 8 weeeks, 4 months, 6 months
IGF-1
Measured: 8 weeks, 4 months, 6 months
Mean total daily caloric intake
Measured: 8 weeks, 4 months, 6 months
Mean total daily caloric expenditure
Measured: 8 weeks, 4 months, 6 months
Suppression of hepatic glucose production by clamp
Measured: 8 weeks, 6 months
Resting energy expenditure by calorimetry
Measured: 8 weeks, 6 months
Oxidative and non-oxidative glucose disposal by clamp
Measured: 8 weeks, 6 months
Total energy expenditure under hyperinsulinemia by clamp
Measured: 8 weeks, 6 months
Fat oxidation under hyperinsulinemia by clamp
Measured: 8 weeks, 6 months
Fatty acid suppression under hyperinsulinemia by clamp
Measured: 8 weeks, 6 months
Adverse events
Measured: 8 weeks, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Funding expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanley Hsia, MD, Principal investigator, Charles Drew University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877513
- Sponsor's protocol ID
- 08-02-2165
- Status last verified
- Feb 2014
- First submitted
- 23 Feb 2009
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in Smokers Undergoing Smoking Cessation
- ClinicalTrials.gov ID
- NCT00877513
- Acronym / sponsor ID
- 08-02-2165
- Conditions
- Cardiovascular Disease, Insulin Resistance
- Keywords
- Smoking, Insulin resistance, Metabolic syndrome, Body fat distribution, Cigarette smoking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding expired
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Apr 2009 (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.
Cigarette smoking increases CVD risk and worsens insulin resistance, but also contributes to weight loss; smoking cessation reduces CVD risk and improves insulin sensitivity, but also contributes to weight gain. The mechanisms that underlie these metabolic changes of cigarette smoking and smoking cessation on insulin resistance, body composition, and fat distribution are poorly understood.
Detailed description
This study is a prospective, open cohort study of smokers who undergo a smoking cessation program, and who subsequently may or may not resume smoking spontaneously. Eligible subjects will be characterized at baseline with respect to their metabolic and CVD risk profiles, body fat composition and distribution. Subjects will then undergo an intensive 8-week smoking cessation program using bupropion plus cognitive behavioral counseling. Those who successfully abstain will be reassessed. Since most individuals who quit smoking will naturally resume smoking again over time, subjects will be assessed again after an additional 4 months of follow-up when a subset of subjects will be expected to have naturally resumed smoking.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Behavioral: Smoking cessationCigarette smokers wishing to quit |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 25 to 70 inclusive; any ethnicity
- Cigarette smoking for at least 3 years, at a rate of at least 1 but not more than 2 packs per day
- BMI 19 kg/m2 or greater and 40 kg/m2 or less
- Willing to enter, and be able to comply with the instructions and scheduled follow-up of a smoking cessation program
Key exclusion criteria (16 listed)
- Any physical disabilities that prevent the subject from participating in the study, as determined by the investigators
- History of CVD (ventricular arrhythmias, atrial arrhythmias with a history of hemodynamic instability, unstable angina, myocardial infarction, invasive coronary revascularization, or any hospitalization for CVD within the last 3 years, NYHA Class III or IV CHF)
- Current abuse of illicit drugs or heavy ethanol use
- History or baseline laboratory evidence of diabetes mellitus
- History of chronic obstructive pulmonary disease (COPD)
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 |
|---|---|---|
| Smoking cessationSmoking cessation program over 8 weeks, consisting of cognitive behavioral counseling every 2 weeks along with adjunctive use of bupropion | Behavioural | Smokers |
Primary outcome
Insulin sensitivity by euglycemic hyperinsulinemic clamp
Time frame: 8 weeks, 6 months
21 secondary outcomes
Body mass index
Time frame: 8 weeks, 4 months, 6 months
Body composition
Time frame: 8 weeks, 4 months, 6 months
Body fat distribution
Time frame: 8 weeks, 4 months, 6 months
Blood pressure
Time frame: 8 weeks, 4 months, 6 months
Fasting lipid profile
Time frame: 8 weeks, 4 months, 6 months
Apolipoproteins
Time frame: 8 weeks, 4 months, 6 months
Fasting plasma glucose
Time frame: 8 weeks, 4 months, 6 months
HOMA-IR index
Time frame: 8 weeks, 4 months, 6 months
Adipokines
Time frame: 8 weeks, 4 months, 6 months
Highly-sensitive C-reactive protein
Time frame: 8 weeks, 4 months, 6 months
Morning cortisol
Time frame: 8 weeeks, 4 months, 6 months
IGF-1
Time frame: 8 weeks, 4 months, 6 months
Mean total daily caloric intake
Time frame: 8 weeks, 4 months, 6 months
Mean total daily caloric expenditure
Time frame: 8 weeks, 4 months, 6 months
Suppression of hepatic glucose production by clamp
Time frame: 8 weeks, 6 months
Resting energy expenditure by calorimetry
Time frame: 8 weeks, 6 months
Oxidative and non-oxidative glucose disposal by clamp
Time frame: 8 weeks, 6 months
Total energy expenditure under hyperinsulinemia by clamp
Time frame: 8 weeks, 6 months
Fat oxidation under hyperinsulinemia by clamp
Time frame: 8 weeks, 6 months
Fatty acid suppression under hyperinsulinemia by clamp
Time frame: 8 weeks, 6 months
Adverse events
Time frame: 8 weeks, 4 months, 6 months
Results and safety
The study was stopped early (reason given: Funding expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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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.
Stanley Hsia, MD principal investigator
Charles Drew University of Medicine and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation in people with Cardiovascular Disease and Insulin Resistance, run by Charles Drew University of Medicine and Science 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 4 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: stopped early, as of the sponsor's last update on 11 Feb 2014. 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?
The study was stopped early (reason given: Funding expired). 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?
Insulin sensitivity by euglycemic hyperinsulinemic clamp (time frame: 8 weeks, 6 months). 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 11 Feb 2014.