search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status
Active
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
Poznan University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Poznan University of Medical Sciences
  • Poznan University of Physical Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Ov/Ob group

N group

H group

Arm Description

PCOS subjects (Overweight/Obesity)

PCOS subjects (Normal weight)

Healthy control subjects

Outcomes

Primary Outcome Measures

Blood parameters
Hormonal and biochemical parameters, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone, androstenedione, estradiol, dehydroepiandrosterone (DHEA-S), Sex Hormone Binding Globulin (SHBG), fasting glucose and fasting insulin, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG), 17 OH-Progesterone, Prolactin, Cortisol, Thyroid-stimulating hormone (TSH), will be measured in the morning after overnight fasting.
Anthropometric Assessment
Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height². Weight will be measured to the nearest 0.1 kg using digital medical scales. Height will be measured with a stadiometer attached to the scales. Waist circumference (WC) will be measured to the nearest 0.1 mm using anthropometric tape between the lower border of rib margin and the upper border of iliac crest (WC-mid).
Body Composition
Body composition will be assessed with a body composition analyzer (BIA method). The measurements of fat mass (FM) will be expressed as a percentage (%) and kilograms (kg).

Secondary Outcome Measures

Full Information

First Posted
January 21, 2021
Last Updated
December 24, 2022
Sponsor
Poznan University of Physical Education
Collaborators
National Science Centre, Poland, Poznan University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT04738409
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Physical Education
Collaborators
National Science Centre, Poland, Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective 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. 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) to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ov/Ob group
Arm Type
Experimental
Arm Description
PCOS subjects (Overweight/Obesity)
Arm Title
N group
Arm Type
Experimental
Arm Description
PCOS subjects (Normal weight)
Arm Title
H group
Arm Type
No Intervention
Arm Description
Healthy control subjects
Intervention Type
Other
Intervention Name(s)
Lifestyle intervention
Intervention Description
The purpose of the research is to evaluate the potential of a multidimensional lifestyle program for PCOS girls. The primary aim is to verify the effectiveness of a 16-week AID intervention vs. HCD (combined with PA&T), in terms of improvement in androgens level and immune-metabolic risk parameters
Primary Outcome Measure Information:
Title
Blood parameters
Description
Hormonal and biochemical parameters, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone, androstenedione, estradiol, dehydroepiandrosterone (DHEA-S), Sex Hormone Binding Globulin (SHBG), fasting glucose and fasting insulin, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG), 17 OH-Progesterone, Prolactin, Cortisol, Thyroid-stimulating hormone (TSH), will be measured in the morning after overnight fasting.
Time Frame
2018-2022
Title
Anthropometric Assessment
Description
Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height². Weight will be measured to the nearest 0.1 kg using digital medical scales. Height will be measured with a stadiometer attached to the scales. Waist circumference (WC) will be measured to the nearest 0.1 mm using anthropometric tape between the lower border of rib margin and the upper border of iliac crest (WC-mid).
Time Frame
2018-2022
Title
Body Composition
Description
Body composition will be assessed with a body composition analyzer (BIA method). The measurements of fat mass (FM) will be expressed as a percentage (%) and kilograms (kg).
Time Frame
2018-2022
Other Pre-specified Outcome Measures:
Title
Disordered Eating Attitudes
Description
Eating behavior will be assessed with a standard Eating Attitudes Test-26 (EAT-26), a self-administrated questionnaire.
Time Frame
2018-2022
Title
Inflammation and Oxidative Stress
Description
Serum concentrations of the inflammation markers: Interleukin 1 (IL-1), Interleukin 6 (IL-1), Tumor Necrosis Factor (TNF-α), C-reactive protein (CRP) and the markers of oxidation: malondialdehyde, total antioxidant capacity will be measured with a commercial ELISA assay kits
Time Frame
2018-2022
Title
Nutrition evaluation
Description
Nutrition evaluation will be conducted by continuous recording of all consumed foodstuffs, dishes and beverages, specifying home measures and weight (3-day food record method and food frequency method FFQ). Data will be analysed using The Aliant computer program (Cambridge Diagnostics).
Time Frame
2018-2022
Title
Oral Health Assessment
Description
Severity of gingivitis expressed as a Gingival Index (GI) Presence of gingivitis assessed based on the percentage of sites bleeding upon probing BOP%. The subgingival microflora assessed on the basis of the number of specific bacteria isolated from gingival sulci of every individual and the percentage of patients affected by specific periodontal pathogens. Salivary levels of TNF-alfa, IL-6, IL-1B, uric acid used to assess and compare the inflammation in oral environment. Testosteron in saliva used to compare androgenic status of patients with PCOS and healthy controls.
Time Frame
2018-2022
Title
Evaluation of physical activity
Description
International Physical Activity Questionnaire will be applied, including records of the type and specific character of the training and activity, its duration, intensity and frequency.
Time Frame
2018-2022
Title
The Data From The Child's Health Book
Description
Collected from the child's health book regarding newborn body weight and term of delivery. The incidence of macrosomia (body weight over 4000 g) or low birth weight, LBW (body weight less than 2500 g) was assessed on the basis of the newborn's body weight. The full term of delivery (term births) will be assessed for deliveries that occur between 38-42 weeks of pregnancy, while preterm births will be defined as those deliveries between 23 weeks and 37 weeks
Time Frame
2018-2022

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Małgorzata Mizgier, PhD
Organizational Affiliation
Poznan University of Phisical Education, Dietetic Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Justyna Opydo-Szymaczek, PhD
Organizational Affiliation
Poznan University of Medical Scienses
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grażyna Jarząbek-Bielecka, PhD
Organizational Affiliation
Poznan University of Medical Scienses
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznan
ZIP/Postal Code
61-701
Country
Poland
Facility Name
Poznan University of Physical Education
City
Poznan
ZIP/Postal Code
61-871
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
35010948
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.
Results Reference
derived
PubMed Identifier
34441766
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.
Results Reference
derived
PubMed Identifier
33801995
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs