Weight LossMAMMAREDNCT02659371
Weight Loss Prior Mamma Reduction - A Pilot Study
A study testing Low energy diet in people with Weight Loss and Hypertrophy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Due to a higher risk of complications, obese and overweight patients with macromastia are in Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2. The study is a pilot study with a diet intervention group and no control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Weight Loss, Hypertrophy
- What is being tested?
- Low energy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- entitled to mammoplasty,
- motivated towards participation in a weight loss program
- BMI within the range 25.5 to 35 kg/m2
Who cannot join
- more than 65 years of age
- insulin-dependent diabetes
- chronic heart, liver or kidney failure
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital at Herlev (EFFECT)
Herlev, Herlev, 2730
About this study
Official title: Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - A Pilot Study
Due to a higher risk of complications, obese and overweight patients with macromastia are in Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2.
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.
- Conditions
- Weight Loss, Hypertrophy
- Being tested
- Low energy diet
- Medical subject headings
- Weight Loss, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low energy dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Low energy diet | Experimental | Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d. Receives: Dietary Supplement: Low energy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measurement of weight to nearest 0.1 kg on category III approved body weight
Measured: 12 weeks
Secondary outcomes (3)
Breast volumen
measure of breast volumen
Measured: 12 weeks
Breast size
anthropometric measurements of the breasts by measuring tape.
Measured: 12 weeks
Pain and discomfort
Questionnaire on pain in head, neck, shoulders
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Bitz, Copenhagen University Hospital at Herlev
- Investigators
- Arne Astrup, MDDrMedSci, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659371
- Sponsor's protocol ID
- EFFECT.C02.2014
- Acronym
- MAMMARED
- Status last verified
- Aug 2016
- First submitted
- 9 Nov 2015
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - A Pilot Study
- ClinicalTrials.gov ID
- NCT02659371
- Acronym / sponsor ID
- MAMMARED / EFFECT.C02.2014
- Conditions
- Weight Loss, Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to a higher risk of complications, obese and overweight patients with macromastia are in Denmark prohibited mammoplasty , as BMI must be within normal range, i.e. BMI < 25 kg/m2.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low energy diet | Experimental | Dietary Supplement: Low energy dietLow energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- entitled to mammoplasty,
- motivated towards participation in a weight loss program
- BMI within the range 25.5 to 35 kg/m2
Key exclusion criteria (3 listed)
- more than 65 years of age
- insulin-dependent diabetes
- chronic heart, liver or kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low energy diet | Dietary supplement | Low energy diet |
Primary outcome
Weight loss
Time frame: 12 weeks
Measurement of weight to nearest 0.1 kg on category III approved body weight
3 secondary outcomes
Breast volumen
Time frame: 12 weeks
Breast size
Time frame: 12 weeks
Pain and discomfort
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, MDDrMedSci principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low energy diet in people with Weight Loss and Hypertrophy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.