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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659371
Recruitment Status : Completed
First Posted : January 20, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Christian Bitz, Copenhagen University Hospital at Herlev

Study Description
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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.


Condition or disease Intervention/treatment Phase
Weight Loss Hypertrophy Dietary Supplement: Low energy diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 12 weeks ]
    Measurement of weight to nearest 0.1 kg on category III approved body weight


Secondary Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Denmark
Copenhagen University Hospital at Herlev (EFFECT)
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
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Principal Investigator: Arne Astrup, MDDrMedSci University of Copenhagen
More Information
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Responsible Party: Christian Bitz, Head of research, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT02659371    
Other Study ID Numbers: EFFECT.C02.2014
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Hypertrophy
Body Weight Changes
Pathological Conditions, Anatomical