Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
6 participants
INTERVENTIONAL
2015-01-31
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study is a pilot study with a diet intervention group and no control group. The intervention is a 12 week low energy diet pre-operative weight loss program investigating if this will result in weight loss making the overweight and obese patients eligible for breast reduction surgery i.e. BMI \< 25.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Breast Reduction Techniques
NCT04509037
Mastopexy With Autologous Augmentation in Women After Massive Weight Loss - A Clinical, Randomized Study
NCT02572271
Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment
NCT01543711
Nipple Delay Prior to Nipple Sparing Mastectomy: A Pilot RCT
NCT02526719
Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
NCT02592213
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low energy diet
Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d.
Low energy diet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low energy diet
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* motivated towards participation in a weight loss program
* BMI within the range 25.5 to 35 kg/m2
Exclusion Criteria
* insulin-dependent diabetes
* chronic heart, liver or kidney failure
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Copenhagen University Hospital at Herlev
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christian Bitz
Head of research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arne Astrup, MDDrMedSci
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Copenhagen University Hospital at Herlev (EFFECT)
Herlev, Herlev, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EFFECT.C02.2014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.