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Weight Loss Prior Mamma Reduction - A Pilot Study (MAMMARED)

C

Copenhagen University Hospital at Herlev

Status

Completed

Conditions

Weight Loss
Hypertrophy

Treatments

Dietary Supplement: Low energy diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02659371
EFFECT.C02.2014

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Low energy diet
Experimental group
Description:
Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d.
Treatment:
Dietary Supplement: Low energy diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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