- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560439
Diabetes Prevention Program (METFIT) in Reducing Insulin Resistance in Stage I-III Breast Cancer Survivors
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
Study Overview
Status
Conditions
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIA Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage III Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage IIIC Breast Cancer AJCC v8
- Early-Stage Breast Carcinoma
Intervention / Treatment
Detailed Description
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:
Patients undergo METFIT program for 16 sessions over 6 months.
After completion of study treatment, patients are followed up for 40 days.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (METFIT program)
Patients undergo METFIT program for 16 sessions over 6 months.
|
Undergo METFIT program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fidelity
Time Frame: 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.
|
Up to week 8 of intervention
|
Retention
Time Frame: 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.
|
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in insulin resistance (IR)
Time Frame: Baseline to 6 months
|
Assessed by Homeostatic Model Assessment of Insulin Resistance [HOMA-IR]).
The HOMA-IR scores of each subject will be compared to their HOMA-IR scores after the intervention using a paired t-test analysis.
|
Baseline to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Raynald Samoa, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19447 (Other Identifier: City of Hope Comprehensive Cancer Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2020-04551 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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