Weight Loss Prior Mamma Reduction - A Pilot Study

Weight Loss Clinical Trial

— MAMMARED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02659371
• Other study ID #: EFFECT.C02.2014
• Status: Completed
• Phase: N/A
• First received: November 9, 2015
• Last updated: August 3, 2016
• Start date: January 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Hypertrophy
• Weight Loss

Intervention

Dietary Supplement:
• Low energy diet

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital at Herlev (EFFECT)	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood bio markers	Blood sampling and analyses of blood bio markers, e.g. lipids	12 weeks	No
Other	Hip circumference	Measurements of hip circumference to nearest 0.1 cm by measuring tape, repeated three times.	12 weeks	No
Other	Waist circumference	Measurements of waist circumference to nearest 0.1 cm by measuring tape, repeated three times.	12 weeks	No
Primary	Weight loss	Measurement of weight to nearest 0.1 kg on category III approved body weight	12 weeks	No
Secondary	Breast volumen	measure of breast volumen	12 weeks	No
Secondary	Breast size	anthropometric measurements of the breasts by measuring tape.	12 weeks	No
Secondary	Pain and discomfort	Questionnaire on pain in head, neck, shoulders	12 weeks	No