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

Weight Loss by Low Energy Diet as Treatment Prior Mamma Reduction in Overweight Women - 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.

Study Overview

• Status: Completed
• Conditions: Hypertrophy; Weight Loss
• Intervention / Treatment: Dietary supplement: Low energy diet

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Copenhagen University Hospital at Herlev (EFFECT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Measurement of weight to nearest 0.1 kg on category III approved body weight	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast volumen	measure of breast volumen	12 weeks
Breast size	anthropometric measurements of the breasts by measuring tape.	12 weeks
Pain and discomfort	Questionnaire on pain in head, neck, shoulders	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood bio markers	Blood sampling and analyses of blood bio markers, e.g. lipids	12 weeks
Hip circumference	Measurements of hip circumference to nearest 0.1 cm by measuring tape, repeated three times.	12 weeks
Waist circumference	Measurements of waist circumference to nearest 0.1 cm by measuring tape, repeated three times.	12 weeks

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev
• Investigators: Principal Investigator: Arne Astrup, MDDrMedSci, University of Copenhagen

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: January 15, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Body Weight Changes; Weight Loss; Body Weight; Hypertrophy
• Other Study ID Numbers: EFFECT.C02.2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No