Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06429618
• Other study ID #: 01/07 22.01.2024
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
• Contact: Mujde Can Ibanoglu
• Phone: 05323089488
• Email: Drmujdecan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Diet Habit
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demographic datas on the study	Age	3 months
Primary	Evaluation of demographic data	Smoking	3 months
Primary	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
Primary	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
Primary	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
Primary	Hormone results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	prolactin (ng/mL)	3 months
Primary	androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	androstenedione (mosm/kg)	3 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Glucose at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	fasting blood glucose	3 months
Primary	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