Brown adipose tissue responses in PCOS with infrared thermography and inositol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares brown adipose tissue–related heat responses across three groups: women with PCOS and normal BMI, women with PCOS who are overweight or obese, and healthy controls. Brown adipose tissue activity will be assessed non-invasively using infrared thermography of the supraclavicular region, along with serum UCP-1 and a range of metabolic and hormonal measurements. Overweight/obese PCOS participants will receive 12 weeks of oral inositol, with reassessment of thermal and laboratory parameters at the end of treatment. The study will also examine relationships between surface temperature changes, diet, physical activity, anthropometrics, and metabolic markers to better understand thermogenic differences in PCOS.

Why it matters

Who can join: the full rules

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

Where it's running

• Bezmialem Vakif University Faculty of Medicine Hospital
  Istanbul, Turkey (Türkiye) Recruiting
• Istanbul Health and Technology University
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Rana Turgut Yaman — Istanbul Health and Technology University
• Study coordinator: Rana Turgut Yaman
• Email: ranaturgut8@hotmail.com
• Phone: +90 506 775 72 28

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.