Trial of Behavioral Weight Loss and Metformin Treatment to Lower Insulin Growth Factor in Cancer Survivors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- IGF-1 Levels
研究概览
简要总结
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 insulin-like growth factor (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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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- Luteinizing hormone-releasing hormone (LHRH) therapy for prostate cancer in men will be permitted.
- •Have a BMI of 25 kg/m^2 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
排除标准
- •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 Estimated glomerular filtration rate (eGFR)<45
- •Have significant hepatic dysfunction [Aspartate aminotransferase (AST)/Alanine transaminase (ALT) ≥ 2 x upper limit of normal (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
- •White blood cell count (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.
研究组 & 干预措施
Self-Directed
In this group, the study staff will meet with you once at the beginning of the study to give you written information about weight management.
干预措施: Self-control weight loss (Behavioral)
Coach Directed Behavioral Weight Loss
The Remote Lifestyle Coaching intervention is based on the Call Center Directed intervention to help you loss weight
干预措施: Coach Directed Behavioral Weight Loss (Behavioral)
Metformin
This group will be given the study drug called Metformin. Metformin comes in tablet form that you take with meals
干预措施: Metformin (Drug)
结局指标
主要结局
IGF-1 Levels
时间窗: 6 months
Insulin-like growth factor (IGF)-1 levels (ng/ml) at 6 months.
次要结局
- IGF-1 Levels(12 months)
- IGF-1 to IGFBP3 Level Ratio (Molar Ratio)(6 months)