Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- demographic datas on the study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
demographic datas on the study
时间窗: 3 months
Age
Evaluation of demographic data
时间窗: 3 months
Smoking
Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
时间窗: 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.
时间窗: 3 months
waist circumference(centimeters)
androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
时间窗: 3 months
androstenedione (mosm/kg)
dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 3 months
prolactin (ng/mL)
TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
时间窗: 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.
时间窗: 3 months
17-OH progesterone (mIU/mL)
Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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. \[HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405\].
次要结局
未报告次要终点
研究者
Mujde Can Ibanoglu
Assoc. Prof
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital