Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet (PCOS)

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

Status: Begins enrollment this month

Conditions: Diet Habit; Polycystic Ovary Syndrome; Adolescent Behavior

Treatments: Dietary Supplement: Low carbonhydrate diet

Study type: Observational

Funder types: Other

Identifiers

NCT06429618

01/07 22.01.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 12 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 4 patient groups

Phenotype A

Description:

PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM

Treatment:

Dietary Supplement: Low carbonhydrate diet

Phenotype B

Description:

PHENOTYPE B: HA+OD

Treatment:

Dietary Supplement: Low carbonhydrate diet

Phenotype C

Description:

PHENOTYPE C: HA+PCOM

Treatment:

Dietary Supplement: Low carbonhydrate diet

Phenotype D

Description:

PHENOTYPE D: OD+PCOM

Treatment:

Dietary Supplement: Low carbonhydrate diet