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
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Insulin Resistance
Behavioral: Smoking cessation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Insulin Resistance in Smokers Undergoing Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Insulin sensitivity by euglycemic hyperinsulinemic clamp [ Time Frame: 8 weeks, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: February 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Smokers
Cigarette smokers wishing to quit
Behavioral: Smoking cessation
Smoking cessation program over 8 weeks, consisting of cognitive behavioral counseling every 2 weeks along with adjunctive use of bupropion

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877513

Locations
United States, California
Charles Drew University of Medicine and Science
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Investigators
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
  More Information

No publications provided

Responsible Party: Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00877513     History of Changes
Other Study ID Numbers: 08-02-2165
Study First Received: February 23, 2009
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:
Smoking
Insulin resistance
Metabolic syndrome
Body fat distribution
Cigarette smoking

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014