Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet
- Conditions
- Polycystic Ovary SyndromeAdolescent BehaviorDiet Habit
- Interventions
- Dietary Supplement: Low carbonhydrate diet
- Registration Number
- NCT06429618
- Lead Sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Phenotype A Low carbonhydrate diet PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM Phenotype B Low carbonhydrate diet PHENOTYPE B: HA+OD Phenotype C Low carbonhydrate diet PHENOTYPE C: HA+PCOM Phenotype D Low carbonhydrate diet PHENOTYPE D: OD+PCOM
- Primary Outcome Measures
Name Time Method demographic datas on the study 3 months Age
Evaluation of demographic data 3 months Smoking
Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months 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.
Evaluation of clinical results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months waist circumference(centimeters)
androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months androstenedione (mosm/kg)
dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months dehydroepiandrosterone sulfate (DHEA-S) (μg/dL)
Evaluation of degree of hirsutism at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months degree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24)
SHBG at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months Hormone test results : sex hormone-binding globulin (SHBG)
Hormone results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months prolactin (ng/mL)
TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months thyroid stimulating hormone (TSH) (mIU/mL)
17-OH progesterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months 17-OH progesterone (mIU/mL)
Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months free and total testosterone (ng/mL)
Lipid profile at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months Lipid profile: Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL).
Glucose at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months fasting blood glucose
Evaluation of insulin resistance at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents. 3 months 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. \[HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405\].
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Etlik Zübeyde Hanım
🇹🇷Ankara, Turkey