Effect of Cryolipolysis on Inflammatory Factors in Obese Postmenopausal Women
2026年6月24日 更新者：Nada Elsayed Mohamed、Cairo University
This study was conducted to investigate the effect of Cryolipolysis on inflammatory factors in obese postmenopausal women.
調査の概要
詳細な説明
The onset of menopause is associated with a low systemic inflammatory status, an inflammation manifested by increased serum levels of the key proinflammatory cytokines, interleukin (IL)-1, IL-6 or tumor necrosis factor α (TNF-α).
Little information is available on menopause-related differences in inflammatory markers. Few studies have compared CRP levels and leptin in women as a function of menopausal status, finding no differences between premenopausal and postmenopausal women. The relationship between hormonal declines associated with menopause and increased serum levels of proinflammatory cytokines is not yet fully understood.
Cryolipolysis selectively destructs the fat cells, by decreasing the subcutaneous fat temperature through controlled cooling without causing any damage to the surrounding tissues Cryolipolysis induces an inflammation and fat cell fibrosis, which causes the death of adipocytes (apoptosis). Macrophages subsequently engulf and digest the dyed adipocytes and, thereby, gradually decreases the fat layer thickness, which may affect the inflammatory body reaction and factors. However, the systemic effect of Cryolipolysis alone was not approved.
研究の種類
介入
入学 (実際)
46
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Cairo、エジプト
- Nada ElSayed Mohamed
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- All participants were postmenopausal women.
- Their ages were ranged from 50 to 60 years old.
- Body mass index was ranged from 30-40 kg/m2.
- Waist to hip Ratio was between 0.8-1.0.
Exclusion Criteria:
- Systematic disease (uncontrolled hypertension, diabetes mellitus).
- Thyroid, liver and kidney dysfunctions.
- Psychiatric disorders.
- Women received any hormonal therapy or received corticosteroids in the last six months prior to the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Cryolipolysis and aerobic exercise group
The participants received cryolipolysis sessions on abdominal region (30 minutes/2 sessions per week for 12 weeks) in addition to moderate intensity Aerobic exercises on treadmill for 30 minutes/ 2sessions per week for 12 weeks.
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Vacuum controllable head with cold temperature range from -10 to 5°C technique was adjusted according to each patient tolerance, after careful patient sensation examination and vital signs evaluation before and after each session.
Cryolipolysis sessions was applied at the hypogastrium area, 5 cm below the umbilicus, for 30 minutes with temperature degree of -5°C using an anti- freezing membrane to avoid cold burn.
After starting the device on, the patient was instructed with safety measures to pull the key off if there was any intolerable abnormal sensation.
Participants received moderate intensity aerobic exercises 2 times/week for 12 weeks by using treadmill.
Each session took about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill with low speed as in warming up (2 sessions/week)
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アクティブコンパレータ：aerobic exercise group
The participants received aerobic exercises on treadmill only for 30 minutes/ 2sessions per week for 12 weeks.
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Participants received moderate intensity aerobic exercises 2 times/week for 12 weeks by using treadmill.
Each session took about 30 minutes as the following: 5 minutes warming up exercises by walking on the treadmill by low speed, 20 minutes walking at moderate intensity (70% of the maximal heart rate) and 5 minutes are cooling down by walking on the treadmill with low speed as in warming up (2 sessions/week)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serum interleukin-6
時間枠：12 weeks
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Serum interleukin-6 (IL-6) levels were measured from venous blood samples using an enzyme-linked immunosorbent assay (ELISA).
IL-6 concentrations were expressed in picograms per milliliter (pg/mL).
The normal serum IL-6 level in healthy adults is generally less than 7 pg/mL, higher level indicates inflammatory conditions.
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12 weeks
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C- Reactive Proteins
時間枠：12 weeks
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Serum C-reactive protein (CRP) levels were measured from venous blood samples using an immunoturbidimetric assay.
CRP concentrations were expressed in milligrams per liter (mg/L).
A CRP value below 5 mg/L is generally considered within the normal range.
Higher levels indicate inflammatory diseases.
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12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Body weight
時間枠：12 weeks
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weight-height scale was used to calculate body weight (kilogram) for all participants before and after intervention.
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12 weeks
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Body mass index
時間枠：12 weeks
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weight-height scale was used to calculate body mass index for all participants before and after intervention, it was calculated by dividing weight in kilogram by height square meters.
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12 weeks
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waist circumference
時間枠：12 weeks
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waist circumference was measured by the tape at the midpoint between the iliac crest and lowest rib margins at the end of normal expiration (centimeter).
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12 weeks
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Hip circumference
時間枠：12 weeks
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Hip circumference was measured by the tape at the level of grater trochanter (centimeter).
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12 weeks
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waist-hip ratio
時間枠：12 weeks
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waist-hip ratio was calculated by dividing waist circumference over hip circumference, before and after the study intervention.
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12 weeks
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Muscle mass
時間枠：12 weeks
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A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess muscle mass (%).
The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically.
The measurement was performed three times, and the average value was calculated.
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12 weeks
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Body fat weight
時間枠：12 weeks
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A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess Body fat weight (KG).
The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically.
The measurement was performed three times, and the average value was calculated.
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12 weeks
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Body fat percentage
時間枠：12 weeks
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A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess Body fat percentage (%).
The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically.
The measurement was performed three times, and the average value was calculated.
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12 weeks
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Visceral fat
時間枠：12 weeks
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A body composition scale (eufy Smart Scale P1 with Bluetooth and its mobile software) was used to assess Visceral fat (%).
The patient stood on the device platform wearing light clothing, maintaining full contact with the electrodes for 30 seconds until measurements were completed and recorded automatically.
The measurement was performed three times, and the average value was calculated.
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12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディチェア：Abeer ElDeeb, Professor、Cairo University
- スタディディレクター：Samira Swdky, Professor、Al-Azhar University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年1月1日
一次修了 (実際)
2025年7月15日
研究の完了 (実際)
2025年7月30日
試験登録日
最初に提出
2026年6月24日
QC基準を満たした最初の提出物
2026年6月24日
最初の投稿 (実際)
2026年6月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月30日
QC基準を満たした最後の更新が送信されました
2026年6月24日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。