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Insulin Resistance in Smokers Undergoing Smoking Cessation

This study has been terminated.
(Funding expired)
Sponsor:
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00877513
First received: February 23, 2009
Last updated: February 7, 2014
Last verified: February 2014

February 23, 2009
February 7, 2014
February 2009
December 2013   (final data collection date for primary outcome measure)
Insulin sensitivity by euglycemic hyperinsulinemic clamp [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
Insulin sensitivity by euglycemic hyperinsulinemic clamp [ Time Frame: 8 weeks, 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00877513 on ClinicalTrials.gov Archive Site
  • Body mass index [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Body fat distribution [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Fasting lipid profile [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Apolipoproteins [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • HOMA-IR index [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Adipokines [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Highly-sensitive C-reactive protein [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Morning cortisol [ Time Frame: 8 weeeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • IGF-1 [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Mean total daily caloric intake [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Mean total daily caloric expenditure [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: No ]
  • Suppression of hepatic glucose production by clamp [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • Resting energy expenditure by calorimetry [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • Oxidative and non-oxidative glucose disposal by clamp [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • Total energy expenditure under hyperinsulinemia by clamp [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • Fat oxidation under hyperinsulinemia by clamp [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • Fatty acid suppression under hyperinsulinemia by clamp [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 8 weeks, 4 months, 6 months ] [ Designated as safety issue: Yes ]
  • Body mass index [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Body fat distribution [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Fasting lipid profile [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Apolipoproteins [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • HOMA-IR index [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Adipokines [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Highly-sensitive C-reactive protein [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Morning cortisol [ Time Frame: 8 weeeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • IGF-1 [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Mean total daily caloric intake [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Mean total daily caloric expenditure [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Suppression of hepatic glucose production by clamp [ Time Frame: 8 weeks, 12 months ] [ Designated as safety issue: No ]
  • Resting energy expenditure by calorimetry [ Time Frame: 8 weeks, 12 months ] [ Designated as safety issue: No ]
  • Oxidative and non-oxidative glucose disposal by clamp [ Time Frame: 8 weeks, 12 months ] [ Designated as safety issue: No ]
  • Total energy expenditure under hyperinsulinemia by clamp [ Time Frame: 8 weeks, 12 months ] [ Designated as safety issue: No ]
  • Fat oxidation under hyperinsulinemia by clamp [ Time Frame: 8 weeks, 12 months ] [ Designated as safety issue: No ]
  • Fatty acid suppression under hyperinsulinemia by clamp [ Time Frame: 8 weeks, 12 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 8 weeks, 6 months, 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Insulin Resistance in Smokers Undergoing Smoking Cessation
Insulin Resistance in Smokers Undergoing Smoking Cessation

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Cardiovascular Disease
  • Insulin Resistance
Behavioral: Smoking cessation
Smoking cessation program over 8 weeks, consisting of cognitive behavioral counseling every 2 weeks along with adjunctive use of bupropion
Experimental: Smokers
Cigarette smokers wishing to quit
Intervention: Behavioral: Smoking cessation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
103
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Both
25 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00877513
08-02-2165
Yes
Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
Not Provided
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP