Insulin Resistance in Smokers Undergoing Smoking Cessation

NCT00877513 | Terminated DMC

• 1 other identifier: 08-02-2165
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease; Insulin Resistance

Keywords

Smoking; Insulin resistance; Metabolic syndrome; Body fat distribution; Cigarette smoking

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity by euglycemic hyperinsulinemic clamp

  8 weeks, 6 months

Secondary Outcomes (21)

• Body mass index

  8 weeks, 4 months, 6 months

• Body composition

  8 weeks, 4 months, 6 months

• Body fat distribution

  8 weeks, 4 months, 6 months

• Blood pressure

  8 weeks, 4 months, 6 months

• Fasting lipid profile

  8 weeks, 4 months, 6 months

Study Arms (1)

Smokers

EXPERIMENTAL

Cigarette smokers wishing to quit

Behavioral: Smoking cessation

Interventions

Smoking cessation BEHAVIORAL

Smoking cessation program over 8 weeks, consisting of cognitive behavioral counseling every 2 weeks along with adjunctive use of bupropion

Smokers

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Insulin Resistance; Smoking; Metabolic Syndrome; Cigarette Smoking

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Stanley Hsia, MD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2009
• First Posted: April 7, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

US (1)