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Completed

NCT Number: NCT06429618

Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet

The aim of the study was to investigate the changes in the clinical and biochemical parameters of adolescents on a low-carbohydrate diet in relation to their PCOS phenotype in the 3rd trimester.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Adolescent Behavior Behavior Behavior, Animal Cysts Diet Habit Endocrine System Diseases Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

12 year–24 year

Sex eligibility

Female

Study type

Observational

Primary location

Etlik Zübeyde Hanım

Ankara, 06000, Turkey (Türkiye)

About this study

Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries, and metabolic abnormalities. In addition, some clinical and laboratory phenotypic features have been defined that were not previously included in the PCOS definition criteria, but which complement the clinical picture and influence the severity and morbidity of the clinical picture. Phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM.For adult patients, internationally recognized diagnostic criteria have been developed based on combinations of otherwise unexplained hyperandrogenism, anovulation and polycystic ovary and are covered by the Rotterdam Consensus Criteria. However, in the adolescent age group, the frequency of anovulatory cycles and associated menstrual irregularities, the frequent symptoms of hyperandrogenism and acne vulgaris in the developmental phase, the problems with testosterone measurement and the prevalence of polycystic ovarian morphology in normal adolescents complicate the diagnosis.

PCOS is a serious clinical and psychological problem for adolescent girls. Key interventions include lifestyle modification, including diet, physical activity and weight loss. These measures have been shown to alter the course of the disease in overweight and obese girls. In particular, it is known that high glycemic index carbohydrate intake and glycemic load lead to a rapid rise in blood glucose levels and increased insulin production.

It is therefore thought that reducing the amount of insulin could have a more positive effect on PCOS than the usual carbohydrates. A low-carbohydrate diet is an effective, weight-independent approach in the treatment of metabolic disorders in PCOS patients. With this in mind, this study aimed to evaluate the clinical and biochemical outcomes at month 3 after application of the low-carbohydrate diet in adolescents according to their PCOS phenotype.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 1 year has passed since menarche
  • under 24 years old
  • patients who have not received an oral contraceptive method and have given verbal and written informed consent will be included.

Exclusion criteria

  • over 24 years old
  • hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia, thyroid diseases
  • neuromuscular, liver, pancreatic or gastrointestinal diseases
  • hormonal medication such as antiandrogens, antidiabetics, glucocorticoids, insulin sensitizers or lipid regulators

Treatment and study plan

Low carbonhydrate diet

Dietary Supplement

Each patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic.

Other names: 0., 3.month

Primary outcomes

  1. demographic datas on the study

    Time frame: 3 months

    Age

  2. Evaluation of demographic data

    Time frame: 3 months

    Smoking

  3. Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    Body mass index Calculation of BMI: Height and body weight of the patients were measured using professionally calibrated devices. BMI was calculated using the formula BMI = weight (kg)/height (m)2.

  4. Evaluation of clinical results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    waist circumference(centimeters)

  5. Evaluation of degree of hirsutism at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    degree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24)

  6. Hormone results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    prolactin (ng/mL)

  7. androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    androstenedione (mosm/kg)

  8. dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    dehydroepiandrosterone sulfate (DHEA-S) (μg/dL)

  9. TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    thyroid stimulating hormone (TSH) (mIU/mL)

  10. SHBG at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    Hormone test results : sex hormone-binding globulin (SHBG)

  11. 17-OH progesterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    17-OH progesterone (mIU/mL)

  12. Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    free and total testosterone (ng/mL)

  13. Lipid profile at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    Lipid profile: Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL).

  14. Glucose at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    fasting blood glucose

  15. Evaluation of insulin resistance at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

    Time frame: 3 months

    Calculation of insulin resistance: A fasting blood glucose level between 100-125 mg/dl was considered as 'impaired fasting glucose'. A Homeostatic Model Assessment Insulin Resistance (HOMA-IR) value of ≥2.5 was defined as insulin resistance. Insulin resistance was calculated using the formula of the homeostatic model. [HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405].

Sponsors and collaborators

Lead sponsor

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Other

Registry information

Official study title

Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome

Acronym: PCOS

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 28, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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