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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography

8 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Turquia (Türkiye)
      • Istanbul, Turquia (Türkiye)
        • Recrutamento
        • Bezmialem Vakif University Faculty of Medicine Hospital
        • Contato:
      • Istanbul, Turquia (Türkiye)
        • Recrutamento
        • Istanbul Health and Technology University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 40 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Healthy Control Group

Healthy women without PCOS who will undergo the study assessments and serve as a reference group.
Sem intervenção: 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.
Experimental: 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.
Suplemento dietético: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Supraclavicular Skin Temperature (Tscv)
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Relative Supraclavicular Skin Temperature (Trel)
Prazo: 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
Prazo: At baseline for all participants

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

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

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

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Istanbul Health and Technology University

Investigadores

  • Investigador principal: Rana Turgut Yaman, Istanbul Health and Technology University
  • Cadeira de estudo: Hayrettin Mutlu, PhD, Istanbul Health and Technology University
  • Diretor de estudo: Seda Ateş, MD, Bezmialem Vakif University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de outubro de 2026

Primeira postagem (Real)

27 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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