Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- demographic datas on the study
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Mujde Can Ibanoglu
Assoc. Prof
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
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
Outcomes
Primary Outcomes
demographic datas on the study
Time Frame: 3 months
Age
Evaluation of demographic data
Time Frame: 3 months
Smoking
Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time Frame: 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.
Time Frame: 3 months
waist circumference(centimeters)
androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time Frame: 3 months
androstenedione (mosm/kg)
dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 3 months
prolactin (ng/mL)
TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time Frame: 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.
Time Frame: 3 months
17-OH progesterone (mIU/mL)
Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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. \[HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405\].