Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants

Running, not enrolling · Not applicable

Conditions studied: Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Ductal Breast Carcinoma In Situ, Obesity, Overweight, Premalignant Lesion

In brief

This pilot trial studies how well a diabetes prevention program with or without hunger training works in helping to lower breast cancer risk in obese participants. A diabetes prevention program involves learning about and receiving materials on different strategies to encourage weight loss, and hunger training involves learning how to recognize hunger. It is not yet known whether adding hunger training to a diabetes prevention program helps participants control their weight that could reduce the risk of some cancers.

Key facts

Study ID

NCT03546972

Run by

M.D. Anderson Cancer Center

People needed

51

Starts

2017-12-17

Expected to finish

2026-11-30

Last updated by the study team

2026-04-15

Who can join

Age: 30 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Body Mass Index (BMI) >= 27 kg/m\^2.
• At high risk of developing breast cancer defined by one or more of the following: Gail model lifetime risk > 20% or a 5 year risk >1.66%, a history of deleterious BRCA1/2 mutation or mantle radiation, a history of ductal cancer in situ, or a history of high risk premalignant breast lesion.
• 12 months without a period/menstrual cycle or having had a bilateral oophorectomy.
• Ability to take digital time stamped photos.
• Internet access (daily).
• Reports being proficient in English (can read/write and speak fluently).

You may not qualify if…

• Previous participation in this trial. Participation is defined as screening. Re-screening is not allowed except for individuals excluded for BMI. Patients previous screened as ineligible due to BMI are allowed to be re-screened and enrolled if eligible.
• Has a current measured BMI less than 27 kg/m\^2.
• Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.
• Currently being actively treated for cancer other than nonmelanoma skin cancer.
• Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
• Reported current diagnosis or history of type I diabetes or type 2 diabetes.
• Reported use of oral antidiabetic agents (OADs).
• Current use of any drug (except metformin) or anticipated change in concomitant medication, which the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids).
• Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator).
• Previous or current treatment with GLP-1 receptor agonists (e.g. exenatide, liraglutide).
• Fasting blood glucose level > 126 and glycosylated hemoglobin (HbA1c) > 7%.
• Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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