Weight Loss Prior Mamma Reduction - A Pilot Study | NCT02659371

Studies
Weight Loss Prior Mamma Reduction - A Pilot Study

NCT02659371

Sponsor

Copenhagen University Hospital at Herlev

Status

Completed

Last Update Posted

Aug 4, 2016Estimated

Enrollment

6Actual

Phase

Not Applicable

Conditions

Weight Loss
Hypertrophy

Interventions

Low energy diet

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2015Actual

Completion Date

May 2016Actual

First Submitted Date

Nov 9, 2015

First Submission Date that Met QC Criteria

Jan 15, 2016

First Posted Date

Jan 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Bitz, Head of research, Copenhagen University Hospital at HerlevPrincipal Investigator

Lead Sponsor

Copenhagen University Hospital at HerlevOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low energy diet	Experimental	Low energy diet (800 kcal/d) for eight weeks, following 4 weeks on reintroduction supplying 1200 kcal/d.	Dietary Supplement: Low energy diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low energy diet	Dietary Supplement		Low energy diet

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Breast volumen	measure of breast volumen	12 weeks
Breast size	anthropometric measurements of the breasts by measuring tape.	12 weeks

Other Outcomes

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.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arne Astrup, MDDrMedSci	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital at Herlev (EFFECT)		Herlev	Herlev	2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss
D006984	Hypertrophy

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D031204	Caloric Restriction

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D002149	Energy Intake

Browse Leaves

Not provided

Browse Branches

Not provided