Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)

Poznan University of Physical Education

Status: Active, not recruiting

Conditions: Polycystic Ovary Syndrome

Treatments: Other: Lifestyle intervention; Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls

Study type: Interventional

Funder types: Other

Identifiers

NCT04738409

HA000001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Ov/Ob group

Experimental group

Description:

PCOS subjects (Overweight/Obesity)

Treatment:

Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls

Other: Lifestyle intervention

N group

Experimental group

Description:

PCOS subjects (Normal weight)

Treatment:

Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls

Other: Lifestyle intervention

H group

No Intervention group

Description:

Healthy control subjects