NCT03546972Active, not recruiting
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
Choosing Health and Cancer Risk Reduction Through Good Eating and Exercise
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 14 May 2018
- Start date
- 17 Dec 2017
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Obesity
- NCT number
- NCT03546972
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 17 Dec 2017 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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).
Other illness
- Currently being actively treated for cancer other than nonmelanoma skin cancer.
- Reported current diagnosis or history of type I diabetes or type 2 diabetes.
Lab values
- Reports being unwilling to use Continuous Glucose Monitor (CGM), which requires daily blood sampling by finger pricks.
- 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).
- Fasting blood glucose level \> 126 and glycosylated hemoglobin (HbA1c) \> 7%.
Other
- Has a current measured BMI less than 27 kg/m\^2.
- Known inability to participate in the ongoing appointments for the four months of the study and scheduled follow-up tests.
- Reported use of oral antidiabetic agents (OADs).
- Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
Who the study is looking for
- 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).
Age in the registry: 30 years to 70 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.