Clinical Trials Directory

Trials / Completed

CompletedNCT06429618

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
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital · Academic / Other
Sex
Female
Age
12 Years – 24 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTLow carbonhydrate dietEach 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.

Timeline

Start date
2024-09-30
Primary completion
2024-10-07
Completion
2025-02-25
First posted
2024-05-28
Last updated
2025-02-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06429618. Inclusion in this directory is not an endorsement.