Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429618
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-18
Brief Title:
Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet
Sponsor:
Etlik Zubeyde Hanım Womens Health Care Training and Research Hospital
Organization:
Etlik Zubeyde Hanım Womens Health Care Training and Research Hospital
Study Overview
Official Title:
Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCOS
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 andor biochemical symptoms of hyperandrogenism hirsutism andor 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 PCOMFor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None