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Completed

NCT Number: NCT02659371

Weight Loss Prior Mamma Reduction - 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.

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital at Herlev (EFFECT)

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Energy Diet

Dietary Supplement

Primary outcomes

  1. Weight loss

    Time frame: 12 weeks

    Measurement of weight to nearest 0.1 kg on category III approved body weight

Secondary outcomes

  1. Breast volumen

    Time frame: 12 weeks

    measure of breast volumen

  2. Breast size

    Time frame: 12 weeks

    anthropometric measurements of the breasts by measuring tape.

  3. Pain and discomfort

    Time frame: 12 weeks

    Questionnaire on pain in head, neck, shoulders

Other outcomes

  1. Blood bio markers

    Time frame: 12 weeks

    Blood sampling and analyses of blood bio markers, e.g. lipids

  2. Hip circumference

    Time frame: 12 weeks

    Measurements of hip circumference to nearest 0.1 cm by measuring tape, repeated three times.

  3. Waist circumference

    Time frame: 12 weeks

    Measurements of waist circumference to nearest 0.1 cm by measuring tape, repeated three times.

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Registry information

Official study title

Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - A Pilot Study

Acronym: MAMMARED

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 20, 2016
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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