Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet

NCT06429618 | Completed DMC

• 1 other identifier: 01/07 22.01.2024
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Adolescent Behavior; Diet Habit

Keywords

phenotype; polycystic ovary syndrome; adolescents; low carbonhydrate diet

Outcome Measures

Primary Outcomes (15)

• demographic datas on the study

  Age

  3 months

• Evaluation of demographic data

  Smoking

  3 months

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

  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.

  3 months

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

  waist circumference(centimeters)

  3 months

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

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

  3 months

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

  prolactin (ng/mL)

  3 months

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

  androstenedione (mosm/kg)

  3 months

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

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

  3 months

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

  thyroid stimulating hormone (TSH) (mIU/mL)

  3 months

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

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

  3 months

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

  17-OH progesterone (mIU/mL)

  3 months

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

  free and total testosterone (ng/mL)

  3 months

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

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

  3 months

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

  fasting blood glucose

  3 months

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

  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. \[HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405\].

  3 months

Study Arms (4)

Phenotype A

PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM

Dietary Supplement: Low carbonhydrate diet

Phenotype B

PHENOTYPE B: HA+OD

Dietary Supplement: Low carbonhydrate diet

Phenotype C

PHENOTYPE C: HA+PCOM

Dietary Supplement: Low carbonhydrate diet

Phenotype D

PHENOTYPE D: OD+PCOM

Dietary Supplement: Low carbonhydrate diet

Interventions

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.

Also known as: 0., 3.month

Phenotype A; Phenotype B; Phenotype C; Phenotype D

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted based on the 2018 ESHRE/ASRM guideline: 1. Oligo and/or anovulation\* 2. Clinical and/or biochemical hyperandrogenism \*Oligo and/or anovulation are defined as follows: * It is considered normal in the first year after menarche as part of the pubertal transition * Between 1-3 years after menarche: \< 21 or \> 45 days * 3 years after menarche - perimenopause: \< 21 or \> 35 days or \< 8 cycles per year * 1 year after menarche: \>90 days for each menstrual cycle * Absence of menstruation at the age of 15 years or 3 years after menarche. Identification of phenotype groups: PHENOTYPE A: HA+ OD + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PCOM.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Etlik Zübeyde Hanım

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 36096151 BACKGROUND

• 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.

  PMID: 27664216 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Adolescent Behavior; Feeding Behavior

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavior; Behavior, Animal

Study Officials

• Mujde Can Ibanoglu

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: May 28, 2024
• Study Start: September 30, 2024
• Primary Completion: October 7, 2024
• Study Completion: February 25, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)