Hypertrophy, Weight Loss
Conditions
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTLow energy diet
Sponsors
Copenhagen University Hospital at Herlev
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* entitled to mammoplasty, * motivated towards participation in a weight loss program * BMI within the range 25.5 to 35 kg/m2
Exclusion criteria
* more than 65 years of age * insulin-dependent diabetes * chronic heart, liver or kidney failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 12 weeks | Measurement of weight to nearest 0.1 kg on category III approved body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast size | 12 weeks | anthropometric measurements of the breasts by measuring tape. |
| Pain and discomfort | 12 weeks | Questionnaire on pain in head, neck, shoulders |
| Breast volumen | 12 weeks | measure of breast volumen |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | 12 weeks | Measurements of waist circumference to nearest 0.1 cm by measuring tape, repeated three times. |
| Blood bio markers | 12 weeks | Blood sampling and analyses of blood bio markers, e.g. lipids |
| Hip circumference | 12 weeks | Measurements of hip circumference to nearest 0.1 cm by measuring tape, repeated three times. |
Countries
Denmark
Outcome results
None listed