Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet

NCT ID: NCT06429618

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-02-25

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.

Conditions

Polycystic Ovary Syndrome; Adolescent Behavior; Diet Habit

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Phenotype A

PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM

Low carbonhydrate diet

Intervention Type: 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.

Phenotype B

PHENOTYPE B: HA+OD

Low carbonhydrate diet

Intervention Type: 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.

Phenotype C

PHENOTYPE C: HA+PCOM

Low carbonhydrate diet

Intervention Type: 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.

Phenotype D

PHENOTYPE D: OD+PCOM

Low carbonhydrate diet

Intervention Type: 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.

Interventions

Low 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

0.; 3.month

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Mujde Can Ibanoglu

Assoc. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mujde Can Ibanoglu

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.

Locations

Etlik Zübeyde Hanım

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Joham AE, Pena AS. Polycystic Ovary Syndrome in Adolescence. Semin Reprod Med. 2022 Mar;40(1-02):e1-e8. doi: 10.1055/s-0042-1757138. Epub 2022 Sep 12.

Reference Type: BACKGROUND

PMID: 36096151 (View on PubMed)

Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.

Reference Type: RESULT

PMID: 27664216 (View on PubMed)

Other Identifiers

01/07 22.01.2024

Identifier Type: -

Identifier Source: org_study_id