Weight Loss Prior Mamma Reduction - A Pilot Study (MAMMARED)
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|ClinicalTrials.gov Identifier: NCT02659371|
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : August 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss Hypertrophy||Dietary Supplement: Low energy diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - A Pilot Study|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||May 2016|
Experimental: Low energy diet
Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d.
Dietary Supplement: Low energy diet
- Weight loss [ Time Frame: 12 weeks ]Measurement of weight to nearest 0.1 kg on category III approved body weight
- Breast volumen [ Time Frame: 12 weeks ]measure of breast volumen
- Breast size [ Time Frame: 12 weeks ]anthropometric measurements of the breasts by measuring tape.
- Pain and discomfort [ Time Frame: 12 weeks ]Questionnaire on pain in head, neck, shoulders
- Blood bio markers [ Time Frame: 12 weeks ]Blood sampling and analyses of blood bio markers, e.g. lipids
- Hip circumference [ Time Frame: 12 weeks ]Measurements of hip circumference to nearest 0.1 cm by measuring tape, repeated three times.
- Waist circumference [ Time Frame: 12 weeks ]Measurements of waist circumference to nearest 0.1 cm by measuring tape, repeated three times.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659371
|Copenhagen University Hospital at Herlev (EFFECT)|
|Herlev, Denmark, 2730|
|Principal Investigator:||Arne Astrup, MDDrMedSci||University of Copenhagen|