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Baltimore, Maryland 21207


This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus self-directed weight loss on IGF-1 and IGF-1 to THE IGFBP-III ratio blood levels after 6 and 12 months of intervention. The coach-directed Behavioral Weight Loss arm is a web-based remote delivery and communication system that promotes healthy behavioral changes. The Metformin arm is a pharmaceutical intervention of oral metformin. This is a secondary prevention study for men and women who have survived solid malignant tumors


Inclusion Criteria: - Women and men ages 18 or older - Have been previously diagnosed with a malignant solid tumor, completed their required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment, and have an anticipated treatment-free life span of 12 months or longer. Chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women and anti- LHRH therapy for prostate cancer in men will be permitted. - Have a BMI of 25 kg/m2 or greater and weight <=400 lbs. - Willingness to accept randomization to each of the three arms - Willingness to change diet, physical activity, and weight - Regular access to computer with a reliable Internet connection - Ability to send and receive emails - Ability to complete online forms - Access to phone - Willingness to provide written informed consent Exclusion Criteria: - Women who are breastfeeding, pregnant, or planning pregnancy within the next year - Medication-treated diabetes - Fasting blood glucose >=200 mg/dL, or fasting blood glucose >=126 and <200 mg/dL and HbA1C >=7% - Current or prior regular use of metformin within the past 3 months - Uncontrolled concurrent medical condition likely to limit compliance with the study interventions - Received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed intervention date - Have a prior history of lactic acidosis by self-report - Prior or planned bariatric surgery - Have significant renal disease or dysfunction defined as eGFR<45 - Have significant hepatic dysfunction (AST/ALT ≥ 2 x ULN or reported liver disease) - Self-reported average consumption of > 14 alcoholic drink per week - Currently enrolled or planned to enroll in weight loss program - Hemoglobin <9 g/dl - Platelet count <100 - WBC <2.5 - Plans to relocate from the area within one years - Use of prescription weight loss medication(s) (e.g., lorcaserin, topiramate/phentermine, phentermine, liraglutide, and bupropion/naltrexone), including off label use of drugs for weight loss or over-the-counter weigh loss medications such as Orlistat within the past 6 months.



Primary Contact:

Principal Investigator
Jessica Yeh, PhD
Johns Hopkins University

Backup Contact:


Location Contact:

Baltimore, Maryland 21207
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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