search
Back to results

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

Primary Purpose

Weight Loss, Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low energy diet
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Copenhagen University Hospital at Herlev (EFFECT)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low energy diet

Arm Description

Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Breast volumen
measure of breast volumen
Breast size
anthropometric measurements of the breasts by measuring tape.
Pain and discomfort
Questionnaire on pain in head, neck, shoulders

Full Information

First Posted
November 9, 2015
Last Updated
August 3, 2016
Sponsor
Copenhagen University Hospital at Herlev
search

1. Study Identification

Unique Protocol Identification Number
NCT02659371
Brief Title
Weight Loss Prior Mamma Reduction - A Pilot Study
Acronym
MAMMARED
Official Title
Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Hypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low energy diet
Arm Type
Experimental
Arm Description
Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low energy diet
Primary Outcome Measure Information:
Title
Weight loss
Description
Measurement of weight to nearest 0.1 kg on category III approved body weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Breast volumen
Description
measure of breast volumen
Time Frame
12 weeks
Title
Breast size
Description
anthropometric measurements of the breasts by measuring tape.
Time Frame
12 weeks
Title
Pain and discomfort
Description
Questionnaire on pain in head, neck, shoulders
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Blood bio markers
Description
Blood sampling and analyses of blood bio markers, e.g. lipids
Time Frame
12 weeks
Title
Hip circumference
Description
Measurements of hip circumference to nearest 0.1 cm by measuring tape, repeated three times.
Time Frame
12 weeks
Title
Waist circumference
Description
Measurements of waist circumference to nearest 0.1 cm by measuring tape, repeated three times.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, MDDrMedSci
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital at Herlev (EFFECT)
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Weight Loss Prior Mamma Reduction - A Pilot Study

We'll reach out to this number within 24 hrs