Trials / Terminated
TerminatedNCT00877513
Insulin Resistance in Smokers Undergoing Smoking Cessation
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Charles Drew University of Medicine and Science · Academic / Other
- Sex
- All
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Smoking cessation | Smoking cessation program over 8 weeks, consisting of cognitive behavioral counseling every 2 weeks along with adjunctive use of bupropion |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2009-04-07
- Last updated
- 2014-02-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00877513. Inclusion in this directory is not an endorsement.