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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:RANA TURGUT YAMAN
- 电话号码:+90 506 775 72 28
- 邮箱:ranaturgut8@hotmail.com
学习地点
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Istanbul、土耳其(türkiye)
- 招聘中
- Bezmialem Vakif University Faculty of Medicine Hospital
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接触:
- Seda Ateş, MD
- 电话号码:+90 505 392 92 74
- 邮箱:drsedaates@yahoo.com
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Istanbul、土耳其(türkiye)
- 招聘中
- Istanbul Health and Technology University
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接触:
- Hayrettin Mutlu, PhD
- 电话号码:+90 505 353 55 36
- 邮箱:hayrettin.mutlu@istun.edu.tr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Healthy Control Group
Healthy women without PCOS who will undergo the study assessments and serve as a reference group. |
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无干预: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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实验性的: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Supraclavicular Skin Temperature (Tscv)
大体时间:At baseline for all participants
|
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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relative Supraclavicular Skin Temperature (Trel)
大体时间:At baseline for all participants
|
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
大体时间:At baseline for all participants
|
Body temperature will be measured and reported in degrees Celsius (°C). |
At baseline for all participants
|
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Body Weight
大体时间:At baseline for all participants
|
Body weight will be measured and reported in kilograms (kg). |
At baseline for all participants
|
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Waist Circumference
大体时间:At baseline for all participants
|
Waist circumference will be measured and reported in centimeters (cm). |
At baseline for all participants
|
|
Body Mass Index (BMI)
大体时间:At baseline for all participants
|
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
大体时间:At baseline for all participants
|
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
大体时间:At baseline for all participants
|
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
|
|
Systolic Blood Pressure
大体时间:At baseline for all participants
|
Systolic blood pressure will be measured and reported in millimeters of mercury (mmHg). |
At baseline for all participants
|
|
Diastolic Blood Pressure
大体时间:At baseline for all participants
|
Diastolic blood pressure will be measured and reported in millimeters of mercury (mmHg). |
At baseline for all participants
|
|
Serum Follicle-Stimulating Hormone (FSH)
大体时间:At baseline for all participants
|
Serum FSH concentration will be measured and reported in mIU/mL. |
At baseline for all participants
|
|
Serum Luteinizing Hormone (LH)
大体时间:At baseline for all participants
|
Serum LH concentration will be measured and reported in mIU/mL. |
At baseline for all participants
|
|
LH/FSH Ratio
大体时间:At baseline for all participants
|
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)
大体时间:At baseline for all participants
|
Serum estradiol concentration will be measured and reported in pg/mL. |
At baseline for all participants
|
|
Serum Thyroid-Stimulating Hormone (TSH)
大体时间:At baseline for all participants.
|
Serum TSH concentration will be measured and reported in µIU/mL. |
At baseline for all participants.
|
|
Serum Dehydroepiandrosterone Sulfate (DHEA-S)
大体时间:At baseline for all participants
|
Serum DHEA-S concentration will be measured and reported in µg/dL. |
At baseline for all participants
|
|
Serum Total Testosterone
大体时间:At baseline for all participants
|
Serum total testosterone concentration will be measured and reported in ng/mL. |
At baseline for all participants
|
|
Modified Ferriman-Gallwey (mFG) Hirsutism Score
大体时间: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
|
|
Fasting Serum Glucose
大体时间:At baseline for all participants
|
Fasting serum glucose will be measured after an overnight fast and reported in mg/dL. |
At baseline for all participants
|
|
Hemoglobin A1c (HbA1c)
大体时间:At baseline for all participants.
|
HbA1c will be measured and reported as a percentage (%) of total hemoglobin. |
At baseline for all participants.
|
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Fasting Serum Insulin
大体时间:At baseline for all participants
|
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)
大体时间:At baseline for all participants
|
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
|
|
Serum C-Reactive Protein (CRP)
大体时间:At baseline for all participants
|
Serum CRP concentration will be measured and reported in mg/L. |
At baseline for all participants
|
|
Dietary Intake: Daily Energy Intake
大体时间:At baseline for all participants
|
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
|
|
Physical Activity Level Assessed by the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
大体时间:At baseline for all participants
|
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
|
合作者和调查者
调查人员
- 首席研究员:Rana Turgut Yaman、Istanbul Health and Technology University
- 学习椅:Hayrettin Mutlu, PhD、Istanbul Health and Technology University
- 研究主任:Seda Ateş, MD、Bezmialem Vakif University
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IstanbulHealthTU
- 25-AKD-358 (其他标识符:Turkish Medicines and Medical Devices Agency (TITCK))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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.
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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