Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Investigation of Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
This study will investigate brown adipose tissue-related physiological responses in women with polycystic ovary syndrome (PCOS). Women with PCOS who have normal body mass index, women with PCOS who are overweight or have obesity, and healthy women will be compared. Brown adipose tissue-related heat responses will be evaluated using non-invasive infrared thermography of the supraclavicular region, together with serum UCP-1 levels and metabolic measurements. Participants in the overweight/obesity PCOS group will receive an inositol supplement for 12 weeks, and measurements will be repeated after supplementation. The study will also examine possible relationships between surface temperature responses, dietary intake, physical activity, body measurements, and metabolic and hormonal markers.
調査の概要
詳細な説明
Polycystic ovary syndrome (PCOS) is a common endocrine-metabolic disorder associated with reproductive and metabolic abnormalities, including insulin resistance and excess body weight. Brown adipose tissue is involved in thermogenesis and energy metabolism, and previous studies have reported reduced brown adipose tissue-related activity in women with PCOS. This study aims to further characterize brown adipose tissue-related physiological responses in women with PCOS and to examine whether these responses differ according to body mass index.
Brown adipose tissue-related heat responses will be assessed using infrared thermography of the supraclavicular region. Infrared thermography is a non-invasive, radiation-free method that allows evaluation of surface temperature changes associated with thermogenic responses. Serum UCP-1, a protein associated with brown adipose tissue, will also be measured. These assessments will be considered together with anthropometric measurements, hormonal and metabolic laboratory parameters, 24-hour dietary recall, thermogenic food consumption, and physical activity.
The study includes three groups: women with PCOS and normal body mass index, women with PCOS who are overweight or have obesity, and healthy women without PCOS. Participants in the overweight/obesity PCOS group will receive oral inositol supplementation for 12 weeks. In this group, brown adipose tissue-related thermal responses and relevant laboratory measures will be reassessed after the supplementation period to examine within-group changes.
Infrared thermography assessments will be performed after an overnight fast and during days 4-8 of the menstrual cycle to reduce variability related to hormonal fluctuations and body temperature. Participants will first rest in a thermoneutral environment. A standardized mild cold exposure will then be applied by immersing the hands in cold water for 5 minutes. Thermal images of the supraclavicular region will be obtained using a FLIR E5 Pro thermal imaging system and analyzed using FLIR Thermal Studio software.
The study is expected to provide additional information on the relationship between PCOS, body weight status, and brown adipose tissue-related physiological responses and to explore whether inositol supplementation is associated with changes in these responses.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:RANA TURGUT YAMAN
- 電話番号:+90 506 775 72 28
- メール:ranaturgut8@hotmail.com
研究場所
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Istanbul、トルコ(Türkiye)
- 募集
- Bezmialem Vakif University Faculty of Medicine Hospital
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コンタクト:
- Seda Ateş, MD
- 電話番号:+90 505 392 92 74
- メール:drsedaates@yahoo.com
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Istanbul、トルコ(Türkiye)
- 募集
- Istanbul Health and Technology University
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コンタクト:
- Hayrettin Mutlu, PhD
- 電話番号:+90 505 353 55 36
- メール:hayrettin.mutlu@istun.edu.tr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Female participants aged 18-40 years
- Premenopausal status
- Ability and willingness to provide written informed consent
- For the Overweight/Obesity PCOS - Inositol and Normal-BMI PCOS Reference Group arms:
- Diagnosis of polycystic ovary syndrome (PCOS) established by an obstetrician and gynecologist according to the Rotterdam criteria
- For the Normal-BMI PCOS Reference Group arm:
- BMI 18.5-24.9 kg/m²
- For the Overweight/Obesity PCOS - Inositol arm:
- BMI ≥25 kg/m²
- For the Healthy Control Group arm:
- BMI 18.5-24.9 kg/m²
- Regular menstrual cycles
- Normal ovarian morphology
- No diagnosis of PCOS
Exclusion Criteria:
- Male sex
- Age ≤17 years or ≥41 years
- Menopausal status
- BMI <18.5 kg/m²
- Pregnancy or breastfeeding
- Regular smoking or alcohol consumption
- Being highly physically active, defined as regular exercise during the previous 6 months or being a professional athlete
- Presence of endocrine disorders that may affect the diagnosis of PCOS, including thyroid disease, congenital adrenal hyperplasia, androgen-secreting tumors, or Cushing syndrome
- Any intervention for PCOS treatment within the previous 6 months, including pharmacological treatment or alternative approaches such as acupuncture
- History of ovarian surgery
- Presence of any of the following conditions:
- Secondary hypertension
- Cardiovascular, cerebrovascular, renal, hepatic, thyroid, or pulmonary disease
- Any type of cancer
- Acute infection
- Autoimmune disease
- Severe psychological or neurological disease
- Following a special diet that may affect metabolic rate, including vegetarian, vegan, diabetic, or low-calorie diets
- Regular use of dietary supplements such as probiotics or prebiotics
- History of obesity-specific treatment, including bariatric surgery or anti-obesity medication
- Regular medication use within the previous 3 months or currently, particularly oral contraceptives, hormonal medications, or medications affecting metabolism
研究計画
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:基礎科学
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし:Healthy Control Group
Healthy women without PCOS who will undergo the study assessments and serve as a reference group. |
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介入なし:Normal-BMI PCOS Reference Group
Women with PCOS and BMI 18.5-24.9 kg/m² who will undergo the study assessments without receiving inositol supplementation. |
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実験的:Overweight/Obesity PCOS - Inositol
Women with PCOS and BMI ≥25 kg/m² who will receive oral inositol supplementation at a dose of 700 mg twice daily (1,400 mg/day) for 12 weeks. Study assessments will be performed before and after the supplementation period. |
Participants in the overweight/obesity PCOS arm (BMI ≥25 kg/m²; n=20) will receive an orally administered inositol dietary supplement for 12 weeks. The supplement will provide 700 mg of inositol twice daily (total daily dose: 1,400 mg). The intervention is based on the use of myo-inositol and D-chiro-inositol, which are commonly used in PCOS management. The product will be selected from commercially available dietary supplements approved by the Republic of Türkiye Ministry of Agriculture and Forestry and will comply with applicable national regulations. Participants will be monitored throughout the supplementation period for tolerability and adverse effects. If an adverse effect or intolerance considered related to inositol occurs, the participant will be withdrawn from the study. Study assessments in this arm will be performed at baseline and after the 12-week supplementation period. |
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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Supraclavicular Skin Temperature (Tscv)
時間枠:At baseline for all participants
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Supraclavicular skin temperature (Tscv) will be measured with a FLIR E5 Pro infrared thermal imaging camera after a standardized mild cold exposure protocol (hand immersion in cold water for 5 minutes). Mean temperatures of the right and left supraclavicular regions of interest will be averaged to obtain a single Tscv value, reported in degrees Celsius (°C), as an indicator of brown adipose tissue activity. |
At baseline for all participants
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Serum Uncoupling Protein 1 (UCP-1) Level
時間枠:At baseline for all participants
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Serum UCP-1 concentration will be measured using a commercial human sandwich ELISA kit as a biochemical marker of brown adipose tissue activity and thermogenesis, and reported in ng/L. |
At baseline for all participants
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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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Relative Supraclavicular Skin Temperature (Trel)
時間枠:At baseline for all participants
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Relative supraclavicular skin temperature (Trel) will be calculated as the difference between Tscv and the reference skin temperature (Tref) measured over the sternal region (corpus sterni), a region without brown adipose tissue, on the same thermal image (Trel = Tscv - Tref). Values from the right and left sides will be averaged to obtain a single Trel value, reported in degrees Celsius (°C). |
At baseline for all participants
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Body Temperature
時間枠:At baseline for all participants
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Body temperature will be measured and reported in degrees Celsius (°C). |
At baseline for all participants
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Body Weight
時間枠:At baseline for all participants
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Body weight will be measured and reported in kilograms (kg). |
At baseline for all participants
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Waist Circumference
時間枠:At baseline for all participants
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Waist circumference will be measured and reported in centimeters (cm). |
At baseline for all participants
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Body Mass Index (BMI)
時間枠:At baseline for all participants
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BMI will be calculated as body weight in kilograms divided by the square of height in meters and reported in kg/m². |
At baseline for all participants
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Body Fat Percentage
時間枠:At baseline for all participants
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Body fat percentage will be measured using a household-type Tanita body composition scale (bioelectrical impedance) and reported as a percentage (%) of total body weight. |
At baseline for all participants
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Basal Metabolic Rate
時間枠:At baseline for all participants
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Basal metabolic rate will be estimated using a household-type Tanita body composition scale (bioelectrical impedance) and reported in kilocalories per day (kcal/day). |
At baseline for all participants
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Systolic Blood Pressure
時間枠:At baseline for all participants
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Systolic blood pressure will be measured and reported in millimeters of mercury (mmHg). |
At baseline for all participants
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Diastolic Blood Pressure
時間枠:At baseline for all participants
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Diastolic blood pressure will be measured and reported in millimeters of mercury (mmHg). |
At baseline for all participants
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Serum Follicle-Stimulating Hormone (FSH)
時間枠:At baseline for all participants
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Serum FSH concentration will be measured and reported in mIU/mL. |
At baseline for all participants
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Serum Luteinizing Hormone (LH)
時間枠:At baseline for all participants
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Serum LH concentration will be measured and reported in mIU/mL. |
At baseline for all participants
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LH/FSH Ratio
時間枠:At baseline for all participants
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The LH/FSH ratio will be calculated by dividing serum LH (mIU/mL) by serum FSH (mIU/mL) and reported as a unitless ratio. |
At baseline for all participants
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Serum Estradiol (E2)
時間枠:At baseline for all participants
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Serum estradiol concentration will be measured and reported in pg/mL. |
At baseline for all participants
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Serum Thyroid-Stimulating Hormone (TSH)
時間枠:At baseline for all participants.
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Serum TSH concentration will be measured and reported in µIU/mL. |
At baseline for all participants.
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Serum Dehydroepiandrosterone Sulfate (DHEA-S)
時間枠:At baseline for all participants
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Serum DHEA-S concentration will be measured and reported in µg/dL. |
At baseline for all participants
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Serum Total Testosterone
時間枠:At baseline for all participants
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Serum total testosterone concentration will be measured and reported in ng/mL. |
At baseline for all participants
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Modified Ferriman-Gallwey (mFG) Hirsutism Score
時間枠:At baseline for all participants
|
Hirsutism will be assessed using the modified Ferriman-Gallwey (mFG) scoring system, in which nine androgen-sensitive body areas are each scored from 0 (no terminal hair) to 4 (maximal terminal hair growth). Item scores will be summed to obtain a total score (units on a scale). The minimum score is 0 and the maximum score is 36; higher scores indicate more severe hirsutism (worse outcome). |
At baseline for all participants
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Fasting Serum Glucose
時間枠:At baseline for all participants
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Fasting serum glucose will be measured after an overnight fast and reported in mg/dL. |
At baseline for all participants
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Hemoglobin A1c (HbA1c)
時間枠:At baseline for all participants.
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HbA1c will be measured and reported as a percentage (%) of total hemoglobin. |
At baseline for all participants.
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Fasting Serum Insulin
時間枠:At baseline for all participants
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Fasting serum insulin concentration will be measured and reported in µIU/mL. |
At baseline for all participants
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
時間枠:At baseline for all participants
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HOMA-IR will be calculated as fasting insulin (µIU/mL) × fasting glucose (mg/dL) / 405 and reported as a unitless index. |
At baseline for all participants
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Serum C-Reactive Protein (CRP)
時間枠:At baseline for all participants
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Serum CRP concentration will be measured and reported in mg/L. |
At baseline for all participants
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Dietary Intake: Daily Energy Intake
時間枠:At baseline for all participants
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Dietary intake will be assessed using a 24-hour dietary recall, and total daily energy intake will be reported in kilocalories per day (kcal/day). |
At baseline for all participants
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Physical Activity Level Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
時間枠:At baseline for all participants
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Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Total physical activity will be calculated by multiplying the minutes per week spent in walking, moderate-intensity, and vigorous-intensity activities by their metabolic equivalent (MET) values (3.3, 4.0, and 8.0, respectively) and summing them, and will be reported in MET-minutes per week. The minimum value is 0, with no fixed maximum; higher values indicate greater physical activity (better outcome). |
At baseline for all participants
|
協力者と研究者
捜査官
- 主任研究者:Rana Turgut Yaman、Istanbul Health and Technology University
- スタディチェア:Hayrettin Mutlu, PhD、Istanbul Health and Technology University
- スタディディレクター:Seda Ateş, MD、Bezmialem Vakif University
出版物と役立つリンク
一般刊行物
- Fitz V, Graca S, Mahalingaiah S, Liu J, Lai L, Butt A, Armour M, Rao V, Naidoo D, Maunder A, Yang G, Vaddiparthi V, Witchel SF, Pena A, Spritzer PM, Li R, Tay C, Mousa A, Teede H, Ee C. Inositol for Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis to Inform the 2023 Update of the International Evidence-based PCOS Guidelines. J Clin Endocrinol Metab. 2024 May 17;109(6):1630-1655. doi: 10.1210/clinem/dgad762.
- Oliveira FR, Mamede M, Bizzi MF, Rocha ALL, Ferreira CN, Gomes KB, Candido AL, Reis FM. Brown adipose tissue activity is reduced in women with polycystic ovary syndrome. Eur J Endocrinol. 2019 Nov;181(5):473-480. doi: 10.1530/EJE-19-0505.
- Haq T, Crane JD, Kanji S, Gunn E, Tarnopolsky MA, Gerstein HC, Steinberg GR, Morrison KM. Optimizing the methodology for measuring supraclavicular skin temperature using infrared thermography; implications for measuring brown adipose tissue activity in humans. Sci Rep. 2017 Sep 20;7(1):11934. doi: 10.1038/s41598-017-11537-x.
- Tienforti D, Puocci G, Venditti C, Gizzi V, Pisano C, Cocci E, Perfetto E, D'Alessandro F, Spagnolo L, Baroni MG, Barbonetti A. Metabolic Phenotype Predicts Biochemical Response to Inositol Supplementation in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. Clin Endocrinol (Oxf). 2026 Aug;105(2):237-244. doi: 10.1111/cen.70140. Epub 2026 Apr 7.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IstanbulHealthTU
- 25-AKD-358 (その他の識別子:Turkish Medicines and Medical Devices Agency (TITCK))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data are not planned to be shared because the study involves sensitive clinical and health-related information, and no formal data-sharing framework has been established.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。