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NCT01302379 · ClinicalTrials.gov registry record · NA
Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 333
- Enrollment target
NCT01302379: Completed NA study, sponsored by University of California, San Diego.
NCT01302379 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 333 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01302379, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 333 participants
- Enrollment target
Study Summary
This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months.
Primary Outcome
Insulin measured as percent change from baseline
Interventions
- DRUG Placebo
- DRUG Metformin
- BEHAVIORAL Lifestyle intervention
- BEHAVIORAL Standard printed dietary guidelines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT01302379 record still lists
NCT01302379 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01302379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01302379 about?
NCT01302379 is a clinical study titled "Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors". This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study wil...
What is the current status of trial NCT01302379?
This trial is currently completed. It is a NA study. The enrollment target is 333 participants. The study started on 2011-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01302379?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Lifestyle intervention (BEHAVIORAL), Standard printed dietary guidelines (BEHAVIORAL).
Who is sponsoring clinical trial NCT01302379?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01302379's enrollment target sits among peer trials
333 306th of 2000 higher than 1,695 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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