Clinical trial NCT04738409: Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)
Official title: Ovarian Hyperandrogenism in Adolescent Girls and Concomitant Metabolic Changes, Oxidative Stress, Inflammation, Oral Health and Their Relation to Diet
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
name: Poznan University of Medical Sciences
First posted: 2021-02-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective was

1. to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet.
2. to identify the factors that increase the risk of being overweight and of obesity among adolescents with clinical features of PCOS, related to diet and DEA (Disordered Eating Attitudes)
3. to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake
4. to assess the relation between oral health of girls with PCOS (including condition of periodontium and dental caries) and their dietary habits, hormonal, metabolic and oxidative and inflammatory status.

Detailed description: Hyperandrogenism in women is a state of increased androgen production, manifested by irregular menstrual cycles, a more frequent incidence of infertility, metabolic syndrome, oxidative stress, and inflammation, as well as acne and hirsutism. In addition to ovulation disorders and the multifollicular ovaries structure in an ultrasound examination, hyperandrogenism is a typical clinical feature of the Polycystic Ovary Syndrome (PCOS), which is diagnosed in approximately 8.6% of adolescent girls. Excessive body weight makes it difficult to diagnose at an early stage of the disease and intensifies metabolic and hormonal disorders, as well as those related to oxidative stress and inflammation of the body. Some research studies suggest that PCOS may negatively affect oral health of women, increasing the risk of periodontal problems.

The main purpose of this research was to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet.

The investigators aimed to identify the factors that increase the risk of being overweight and of obesity among adolescents with clinical features of PCOS, related to diet and DEA(Disordered Eating Attitudes).

The objective was also to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake, such as carbohydrates and fiber, protein (animal, plant), fats and cholesterol in normal and overweight/obese girls with clinical features of PCOS.

Additionally, the investigators would like to evaluate the relation between oral health of girls with PCOS (including condition of periodontium and dental caries) and their dietary habits, hormonal, metabolic and oxidative and inflammatory status.

Eligibility criteria: Inclusion Criteria:

The criteria for the patient's inclusion were based on the 2003 Rotterdam criteria, with the presence of at least two of the following:

* written consent for inclusion (girls and their parents)
* clinical and/or biochemical hyperandrogenism (hirsutism with moderate to severe acne, and/or elevation of serum total testosterone or free testosterone,
* oligoovulation (based on oligomenorrhea defined as bleeding episodes occurring less than 8 times per year or secondary amenorrhea),
* polycystic ovarian picture in an ultrasound examination (at least 12 follicles in each ovary each measuring 2-9 mm in diameter and/or ovarian volume \>10 mL).

Exclusion Criteria:

* any systemic disease, thyroid dysfunction, diabetes, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of pituitary adenoma and androgen-secreting tumors
* medications of continuous use,
* the use of hormonal therapy or antibiotics in the past three months,
* vitamin or supplements use,
* alcohol consumption
* smoking

Primary outcomes:
measure: Blood parameters
timeFrame: 2018-2022
measure: Anthropometric Assessment
timeFrame: 2018-2022
measure: Body Composition
timeFrame: 2018-2022
Secondary outcomes:
Other outcomes:
measure: Disordered Eating Attitudes
timeFrame: 2018-2022
measure: Inflammation and Oxidative Stress
timeFrame: 2018-2022
measure: Nutrition evaluation
timeFrame: 2018-2022
measure: Oral Health Assessment
timeFrame: 2018-2022
measure: Evaluation of physical activity
timeFrame: 2018-2022
measure: The Data From The Child's Health Book
timeFrame: 2018-2022
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: Poznan
country: Poland
facility: Poznan University of Physical Education
Study officials:
affiliation: Poznan University of Phisical Education, Dietetic Department
name: Małgorzata Mizgier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poznan University of Medical Scienses
name: Justyna Opydo-Szymaczek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poznan University of Medical Scienses
name: Grażyna Jarząbek-Bielecka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mizgier M, Watrowski R, Opydo-Szymaczek J, Jodlowska-Siewert E, Lombardi G, Kedzia W, Jarzabek-Bielecka G. Association of Macronutrients Composition, Physical Activity and Serum Androgen Concentration in Young Women with Polycystic Ovary Syndrome. Nutrients. 2021 Dec 24;14(1):73. doi: 10.3390/nu14010073.
citation: Mizgier M, Jarzabek-Bielecka G, Formanowicz D, Jodlowska-Siewert E, Mruczyk K, Cisek-Wozniak A, Kedzia W, Opydo-Szymaczek J. Dietary and Physical Activity Habits in Adolescent Girls with Polycystic Ovary Syndrome (PCOS)-HAstudy. J Clin Med. 2021 Aug 5;10(16):3469. doi: 10.3390/jcm10163469.
citation: Mizgier M, Jarzabek-Bielecka G, Wendland N, Jodlowska-Siewert E, Nowicki M, Brozek A, Kedzia W, Formanowicz D, Opydo-Szymaczek J. Relation between Inflammation, Oxidative Stress, and Macronutrient Intakes in Normal and Excessive Body Weight Adolescent Girls with Clinical Features of Polycystic Ovary Syndrome. Nutrients. 2021 Mar 10;13(3):896. doi: 10.3390/nu13030896.