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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042412
Receipt No. 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

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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
Institute Celal Bayar University, School of Medicine


Institute
Department

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
URL(English) https://upload.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


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