Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography

8 listopada 2026 zaktualizowane przez: Rana Turgut Yaman, Istanbul Health and Technology University

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

      • Istanbul, Turcja (Türkiye)
        • Rekrutacyjny
        • Bezmialem Vakif University Faculty of Medicine Hospital
        • Kontakt:
      • Istanbul, Turcja (Türkiye)
        • Rekrutacyjny
        • Istanbul Health and Technology University
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 40 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Healthy Control Group

Healthy women without PCOS who will undergo the study assessments and serve as a reference group.

Brak interwencji: 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.

Eksperymentalny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Supraclavicular Skin Temperature (Tscv)
Ramy czasowe: 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
Serum Uncoupling Protein 1 (UCP-1) Level
Ramy czasowe: At baseline for all participants

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Relative Supraclavicular Skin Temperature (Trel)
Ramy czasowe: 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
Body Temperature
Ramy czasowe: At baseline for all participants

Body temperature will be measured and reported in degrees Celsius (°C).

At baseline for all participants
Body Weight
Ramy czasowe: At baseline for all participants

Body weight will be measured and reported in kilograms (kg).

At baseline for all participants
Waist Circumference
Ramy czasowe: At baseline for all participants

Waist circumference will be measured and reported in centimeters (cm).

At baseline for all participants
Body Mass Index (BMI)
Ramy czasowe: 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
Body Fat Percentage
Ramy czasowe: 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
Basal Metabolic Rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: At baseline for all participants

Serum LH concentration will be measured and reported in mIU/mL.

At baseline for all participants
LH/FSH Ratio
Ramy czasowe: 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
Serum Estradiol (E2)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: At baseline for all participants.

HbA1c will be measured and reported as a percentage (%) of total hemoglobin.

At baseline for all participants.
Fasting Serum Insulin
Ramy czasowe: At baseline for all participants

Fasting serum insulin concentration will be measured and reported in µIU/mL.

At baseline for all participants
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Rana Turgut Yaman, Istanbul Health and Technology University
  • Krzesło do nauki: Hayrettin Mutlu, PhD, Istanbul Health and Technology University
  • Dyrektor Studium: Seda Ateş, MD, Bezmialem Vakif University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 listopada 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

8 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 października 2026

Pierwszy wysłany (Rzeczywisty)

27 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • IstanbulHealthTU
  • 25-AKD-358 (Inny identyfikator: Turkish Medicines and Medical Devices Agency (TITCK))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .