Phase
Condition
Carcinoma
Obesity
Hypertriglyceridemia
Treatment
Questionnaire Administration
Extended Release Metformin Hydrochloride
Bronchoscopy
Clinical Study ID
Ages > 30 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Former smokers (male and female) with a >= 20 pack year smoking history
Quit smoking >= 12 months prior to enrollment
Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCOm2012) LungCancer Risk Prediction Score > 1.34%
Overweight
Body mass index (BMI) > 25 and
Waist circumference
Female > 88 cm (35")
Male > 102 cm (40")
Age greater than 30 years. Participants younger than 30 years are unlikely to accrueenough smoking exposure followed by enough time after quitting (>12 months) toqualify
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Leukocytes >= 3,000/microliter
Absolute neutrophil count (ANC) >= 1,000/microliter
Platelets >= 100,000/microliter
Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x IULN
Estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73 m^2 (eGFR will becalculated using the equation Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine)
Patients with a history of hepatitis C virus (HCV) infection must have been treatedand cured
Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) areeligible
The effects of metformin ER on the developing human fetus at the recommendedtherapeutic dose are unknown. For this reason, women of child-bearing potential andmen must agree to use adequate contraception (hormonal or barrier method of birthcontrol; abstinence) prior to study entry and for the duration of studyparticipation. Should a woman become pregnant or suspect she is pregnant whileparticipating in this study, she should inform her study physician immediately
Ability to understand and the willingness to sign a written informed consentdocument
Exclusion
Exclusion Criteria:
Current or previous diagnosis of diabetes mellitus (type I or type II diabetes)
Use of metformin within the past 2 years
Use of GLP-1 agonists within 6 weeks prior to enrollment
Glycosylated hemoglobin A1C (HbA1c) > 8%
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to metformin ER
Participants currently using immunosuppressive medication, including systemicsteroids (not inhalational) and episodic use of inhaled steroids are excluded fromthis trial due to the potential impact of these treatments on the primary trialendpoint
Participants receiving any other investigational agents
History of chronic alcohol use or abuse defined by any one of the following:
Average consumption of 3 or more alcohol containing beverages daily in the past 12 months
Consumption of 7 or more alcoholic beverages within a 24 hour period in thepast 12 months
Acute or chronic liver disease, evidence of hepatitis (infectious or autoimmune),cirrhosis or portal hypertension
History of or current condition predisposing to increased risk for lactic acidosissuch as: severe congestive heart failure (New York Heart Association [NYHA] classIII or IV), metabolic acidosis, severe liver disease, or renal failure
Uncontrolled intercurrent illness or psychiatric illness/social situations thatwould or limit compliance with study requirements
Pregnant women are excluded from this study. Metformin ER is a class B agent thatwas not teratogenic in rats and rabbits at doses representing 3 and 6 times themaximum recommended human daily dose of 2000 mg; however, animal reproductionstudies are not always predictive of human response. Because there is an unknown butpotential risk for adverse events (AEs) in nursing infants secondary to treatment ofthe mother with metformin ER, breastfeeding should be discontinued if the mother istreated with metformin ER
Biopsy with invasive carcinoma of the lung or carcinoma in situ
Participants with prior stage 1 non-small cell lung cancer (NSCLC) diagnosisare allowed to participate, as long as there has been 12 months since thecompletion of cancer treatment prior to enrollment with no evidence ofrecurrence or second primary cancer
Study Design
Study Description
Connect with a study center
BC Cancer Research Centre
Vancouver, British Columbia V5Z 1L3
CanadaActive - Recruiting
University of British Columbia Hospital
Vancouver, British Columbia V6T 2B5
CanadaSite Not Available
Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado
Denver, Colorado 80217-3364
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesActive - Recruiting
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