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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000042412
受付番号 R000048376
科学的試験名
一般公開日(本登録希望日) 2020/11/11
最終更新日 2020/11/11

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
The Metabolic implication of the breast reduction
一般向け試験名略称/Acronym
MIOBR
科学的試験名/Scientific Title
The metabolic implication of the breast reduction
科学的試験名略称/Scientific Title:Acronym
MIOBR
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/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.
疾患区分1/Classification by specialty
内分泌・代謝病内科学/Endocrinology and Metabolism 乳腺外科学/Breast surgery
形成外科学/Plastic surgery
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
to evaluate the impact of breast reduction surgery on risk markers of obesity-related diseases.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 説明的/Explanatory
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/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.
副次アウトカム評価項目/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.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 単群/Single arm
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無対照/Uncontrolled
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 1
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1
Breast reduction surgery
Control was 6 months later
介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old より上/<
年齢(上限)/Age-upper limit
65 歳/years-old 未満/>
性別/Gender 女/Female
選択基準/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
除外基準/Key exclusion criteria
Exclusion criteria were cardiovascular diseases, metabolic diseases such as diabetes and Cushing disease, connective tissue diseases, liver diseases, and endocrine disorders.
目標参加者数/Target sample size 35

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Yavuz
ミドルネーム
Kececi
所属組織/Organization
Celal Bayar University
所属部署/Division name
Plastic and Reconstructive Surgery
郵便番号/Zip code 45100
住所/Address
Celal Bayar University, Hafsa Sultan Hastanesi, Yunusmere, Manisa, Turkey
電話/TEL 905323825901
Email/Email yavuz.kececi@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Yavuz
ミドルネーム
Kececi
組織名/Organization
Celal Bayar University
部署名/Division name
Plastic and Reconstructive Surgery
郵便番号/Zip code 45100
住所/Address
Celal Bayar University, Hafsa Sultan Hastanesi, Yunusmere, Manisa, Turkey
電話/TEL 905323825901
試験のホームページURL/Homepage URL
Email/Email yavuz.kececi@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Celal Bayar University, School of Medicine


機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TURKEY
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization その他の国の官庁/Government offices of other countries
研究費拠出国/Nationality of Funding Organization
Turkey

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
None
その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Celal Bayar University, School of Medicine
住所/Address
Celal Bayar University, School of Medicine, Yunusemre, 45100, Manisa
電話/Tel 902362331920
Email/Email etikkurul@cbu.edu.tr

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 11 11

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://data.mendeley.com/datasets/r4vr38m59n/1
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications https://data.mendeley.com/datasets/r4vr38m59n/1
組み入れ参加者数/Number of participants that the trial has enrolled 24
主な結果/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.
主な結果入力日/Results date posted
2020 11 11
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/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.
参加者の流れ/Participant flow
Participants were enrolled before and 6 months after the surgery.
有害事象/Adverse events
None
評価項目/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.
個別症例データ共有計画/Plan to share IPD
https://data.mendeley.com/datasets/r4vr38m59n/1
個別症例データ共有計画の詳細/IPD sharing Plan description
mendeley repository

試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2017 06 28
倫理委員会による承認日/Date of IRB
2017 06 28
登録・組入れ開始(予定)日/Anticipated trial start date
2018 03 14
フォロー終了(予定)日/Last follow-up date
2019 02 05
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2020 11 11
最終更新日/Last modified on
2020 11 11


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048376
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048376

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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