METFIT Program - A Pilot Study Exploring the Feasibility of a Diabetes Prevention Program (DPP)-Based Lifestyle Modification Intervention to Reduce Insulin Resistance in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Retention
研究概览
简要总结
This trial studies how well a diabetes prevention program (METFIT) works in reducing insulin resistance in stage I-III breast cancer survivors. METFIT program, a diet and lifestyle intervention, utilizes intermittent fasting to reduce insulin resistance in insulin resistant breast cancer survivors. Intermittent fasting has been shown to have benefits for patients undergoing cancer therapy by improving symptoms such as fatigue in breast cancer patients. Intermittent fasting has also shown potential for decreasing the risk of breast cancer coming back (recurrence). This trial is being done to determine if METFIT program can be successfully and effectively implemented to reduce insulin resistant in breast cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of the METFIT Program - a 6-month modified Diabetes Prevention Program (DPP)-based lifestyle modification intervention that utilizes intermittent fasting (IF) aimed at reducing insulin resistance (IR) in insulin resistant breast cancer survivors.
SECONDARY OBJECTIVE:
I. To estimate an effect size of the effectiveness of the METFIT Program in reducing IR in insulin resistant breast cancer survivors.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have been treated definitively for early stage breast cancer (I-III) and are 60-180 days from completion of chemotherapy, radiation and surgery regardless of hormonal status
- •Demonstrated at least a 10% weight gain since being diagnosed with breast cancer
- •Demonstrated IR by having a Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score of >= 2.0
- •Demonstrated IR manifested by meeting criteria for metabolic equivalent (MetS) as defined by modified criteria of the National Cholesterol Education Program Adult Treatment Panel (NCEP ATP III) (2005 version) and the World Health Organization (WHO) which includes:
- •Dysregulation of glucose homeostasis demonstrated by a glycosylated hemoglobin (HbA1c) >= 6.5%; OR fasting plasma glucose >= 126 mg/dl (7.0 mmol/L) OR random plasma glucose >= 200 mg/dL (11.1 mmol/L)
- •Plus two of any of the following:
- •Waist circumference in men >= 40 inches and in women >= 35 inches
- •Elevated triglycerides >= 150 mg/dL
- •Low high-density lipoprotein (HDL) cholesterol in men < 40 mg /dL and in women < 50 mg/dL or taking statin medication
- •Elevated blood pressure defined by a systolic pressure >= 130 of a diastolic pressure >= 85 mm Hg or taking anti-hypertensive medication
- •Elevated fasting glucose >= 110 mg/dL
- •Non-smoker (last use 6 months prior to enrollment into the study)
- •Documented informed consent of the participant and/or legally authorized representative
- •Willingness to make substantial changes in their dietary and physical activity behavior
- •Willingness to attend at 70% of the intervention sessions and 100% of the blood draws
- •The effects of IF on the developing fetus of breast cancer survivors are unknown. For this reason, women of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating in the trial, should inform her treating physician immediately
- •Willingness to weigh themselves weekly
- •Willingness to wear a subcutaneous continuous glucose monitor
- •Access to an electronic virtual teleconferencing device and capacity to utilize electronic teleconference technology
排除标准
- •Use of any medication to treat diabetes mellitus
- •Type 2 diabetes
- •History of myocardial infarction or congestive heart failure within the previous 12 months prior to being screened for participation in the study
- •Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
- •Unstable cardiac disease as defined by one of the following:
- •Cardiac events such as myocardial infarction (MI) within the past 6 months
- •New York Heart Association (NYHA) heart failure class III-IV
- •Uncontrolled atrial fibrillation or hypertension
- •History of vascular disease (e.g. deep vein thrombosis, stroke) within six months of starting the intervention
- •Clinically significant uncontrolled illness
- •Women who are pregnant or breastfeeding
- •Any other condition (including psychosocial condition) that would, in the investigator's judgment, contraindicates the patient's participation in the clinical study due to safety concerns with clinical study procedures
- •Any other condition that would confound study results
- •Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
研究组 & 干预措施
Treatment (METFIT program)
Patients undergo METFIT program for 16 sessions over 6 months.
干预措施: Dietary Intervention (Dietary Supplement)
结局指标
主要结局
Retention
时间窗: Up to 6 months
Defined as the rate of participants that complete the intervention and post intervention assessments. Attendance percentage of blood draws and body measurements at both time points. Descriptive quantitative statistics will be used to report retention.
Fidelity
时间窗: Up to week 8 of intervention
The percentage of the cohort that has concordance of glucose trends with diet log to assess adherence to intermittent fasting regimen by week 8 of the intervention. Descriptive quantitative statistics will be used to report fidelity.
次要结局
- Change in insulin resistance (IR)(Baseline to 6 months)