UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042412
Receipt number R000048376
Scientific Title The metabolic implication of the breast reduction
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/11 07:06:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The Metabolic implication of the breast reduction

Acronym

MIOBR

Scientific Title

The metabolic implication of the breast reduction

Scientific Title:Acronym

MIOBR

Region

Asia(except Japan)


Condition

Condition

The augmented risk biomarkers of obesity-related diseases decrease after weight loss with diet or surgical removal of adipose tissue in patients with increased fat storage. Since the breast consists of mainly fat tissue, breast reduction surgery can lessen these augmented levels.

Classification by specialty

Endocrinology and Metabolism Breast surgery Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the impact of breast reduction surgery on risk markers of obesity-related diseases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Preoperative and six months after surgery the levels of fasting blood glucose, insulin, hemoglobinA1c, triglyceride, total cholesterol, low-density lipoprotein, high-density lipoprotein, small dense low-density lipoprotein, macrophage chemotactic protein-1, adiponectin, lipoprotein-associated phospholipase A2, pentraxin-3, chemerin, interferon-gamma, interleukin-6, tumor necrosis factor-alfa, and highly sensitive C reactive protein were compared using Wilcoxon sign test.

Key secondary outcomes

Spearman correlation was used to investigate any relationship between the magnitudes of changes of the laboratory values and body mass index scores, and the amount of removed breast tissue.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Breast reduction surgery
Control was 6 months later

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <

Age-upper limit

65 years-old >

Gender

Female

Key inclusion criteria

Women who requested breast reduction surgery.
Each patient had breast hypertrophy with a distance between suprasternal notch and nipple greater than 28cm

Key exclusion criteria

Exclusion criteria were cardiovascular diseases, metabolic diseases such as diabetes and Cushing disease, connective tissue diseases, liver diseases, and endocrine disorders.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Yavuz
Middle name
Last name Kececi

Organization

Celal Bayar University

Division name

Plastic and Reconstructive Surgery

Zip code

45100

Address

Celal Bayar University, Hafsa Sultan Hastanesi, Yunusmere, Manisa, Turkey

TEL

905323825901

Email

yavuz.kececi@gmail.com


Public contact

Name of contact person

1st name Yavuz
Middle name
Last name Kececi

Organization

Celal Bayar University

Division name

Plastic and Reconstructive Surgery

Zip code

45100

Address

Celal Bayar University, Hafsa Sultan Hastanesi, Yunusmere, Manisa, Turkey

TEL

905323825901

Homepage URL


Email

yavuz.kececi@gmail.com


Sponsor or person

Institute

Celal Bayar University, School of Medicine


Institute

Department

Personal name



Funding Source

Organization

THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TURKEY

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Turkey


Other related organizations

Co-sponsor

None

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Celal Bayar University, School of Medicine

Address

Celal Bayar University, School of Medicine, Yunusemre, 45100, Manisa

Tel

902362331920

Email

etikkurul@cbu.edu.tr


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 11 Day


Related information

URL releasing protocol

https://data.mendeley.com/datasets/r4vr38m59n/1

Publication of results

Unpublished


Result

URL related to results and publications

https://data.mendeley.com/datasets/r4vr38m59n/1

Number of participants that the trial has enrolled

24

Results

Thirty-five patients were enrolled in the study. Twenty-four patients came to a six-month evaluation, so the study was conducted on these 24 patients' data. The mean age of the patients was 46.7 years. The mean weight of the breast tissue removed during surgery was 1705 grams.

Results date posted

2020 Year 11 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The patients who underwent reduction mammoplasty operations between March 2018 and February 2019 were enrolled in the study. Each patient had breast hypertrophy with a distance between suprasternal notch and nipple greater than 28cm. Exclusion criteria were cardiovascular diseases, metabolic diseases such as diabetes and Cushing disease, connective tissue diseases, liver diseases, and endocrine disorders. The study was performed according to the Declaration of Helsinki. Informed written consent was obtained from each subject, and the Institutional Ethics Committee approved this study (28.06.2017- 2O.478.486). The superomedial pedicle technique was performed on all patients.

Participant flow

Participants were enrolled before and 6 months after the surgery.

Adverse events

None

Outcome measures

Fasting plasma glucose, triglyceride, total cholesterol, low-density lipoprotein, high-density lipoprotein, and high sensitive C-reactive protein (hsCRP) levels were measured by using the immunoturbidimetric method at Beckman Coulter AU5800 auto-analyzer; serum insulin levels by using chemiluminescence enzyme immunometric method at UniCel 800 Immunoassay System - Beckman Coulter; A1C analysis by using ion changing method at Tosoh G7 HPLC Analyzer.
The serum levels of small dense low-density lipoprotein, Elabscience, Houston, Texas, USA, Monocyte chemoattractant protein-1, IL-6, TNF-alfa, and lipoprotein-associated phospholipase A2, pentraxin-3, interferon-gamma, chemerin, and adiponectin were measured by using commercially available ELISA kits. Anthropometric measurements and laboratory tests were performed preoperatively and six months postoperatively.

Plan to share IPD

https://data.mendeley.com/datasets/r4vr38m59n/1

IPD sharing Plan description

mendeley repository


Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 06 Month 28 Day

Date of IRB

2017 Year 06 Month 28 Day

Anticipated trial start date

2018 Year 03 Month 14 Day

Last follow-up date

2019 Year 02 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 11 Day

Last modified on

2020 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048376


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name