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Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06429618
Acronym
PCOS
Enrollment
60
Registered
2024-05-28
Start date
2024-09-30
Completion date
2025-02-25
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Diet Habit, Polycystic Ovary Syndrome

Keywords

phenotype, polycystic ovary syndrome, adolescents, low carbonhydrate diet

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTLow carbonhydrate diet

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 24 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
demographic datas on the study3 monthsAge
Evaluation of demographic data3 monthsSmoking
Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsBody 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.
Evaluation of clinical results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthswaist circumference(centimeters)
Evaluation of degree of hirsutism at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsdegree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24)
Hormone results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsprolactin (ng/mL)
androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsandrostenedione (mosm/kg)
dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsdehydroepiandrosterone sulfate (DHEA-S) (μg/dL)
TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsthyroid stimulating hormone (TSH) (mIU/mL)
SHBG at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsHormone test results : sex hormone-binding globulin (SHBG)
17-OH progesterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 months17-OH progesterone (mIU/mL)
Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsfree and total testosterone (ng/mL)
Lipid profile at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsLipid profile: Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL).
Glucose at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsfasting blood glucose
Evaluation of insulin resistance at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.3 monthsCalculation 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. \[HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405\].

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026