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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography

8 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
      • Istanbul, Turkije (Türkiye)
        • Werving
        • Bezmialem Vakif University Faculty of Medicine Hospital
        • Contact:
      • Istanbul, Turkije (Türkiye)
        • Werving
        • Istanbul Health and Technology University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 40 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Healthy Control Group

Healthy women without PCOS who will undergo the study assessments and serve as a reference group.
Geen tussenkomst: 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.
Experimenteel: 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.
Voedingssupplement: inositol

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Supraclavicular Skin Temperature (Tscv)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative Supraclavicular Skin Temperature (Trel)
Tijdsspanne: 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
Tijdsspanne: At baseline for all participants

Body temperature will be measured and reported in degrees Celsius (°C).
At baseline for all participants
Body Weight
Tijdsspanne: At baseline for all participants

Body weight will be measured and reported in kilograms (kg).
At baseline for all participants
Waist Circumference
Tijdsspanne: At baseline for all participants

Waist circumference will be measured and reported in centimeters (cm).
At baseline for all participants
Body Mass Index (BMI)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: At baseline for all participants

Serum LH concentration will be measured and reported in mIU/mL.
At baseline for all participants
LH/FSH Ratio
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istanbul Health and Technology University

Onderzoekers

  • Hoofdonderzoeker: Rana Turgut Yaman, Istanbul Health and Technology University
  • Studie stoel: Hayrettin Mutlu, PhD, Istanbul Health and Technology University
  • Studie directeur: Seda Ateş, MD, Bezmialem Vakif University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

8 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

25 oktober 2026

Eerst geplaatst (Werkelijk)

27 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

8 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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