Polycystic Ovary SyndromePCOSNCT06429618
Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet
An observational study of Polycystic Ovary Syndrome and Adolescent Behavior, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Adolescent Behavior, Diet Habit
- What is being tested?
- Low carbonhydrate diet
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2024to 25 Feb 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study will be conducted based on the 2018 ESHRE/ASRM guideline: 1. Oligo and/or anovulation* 2. Clinical and/or biochemical hyperandrogenism *Oligo and/or anovulation are defined as follows: * It is considered normal in the first year after menarche as part of the pubertal transition * Between 1-3 years after menarche: < 21 or > 45 days * 3 years after menarche - perimenopause: < 21 or > 35 days or < 8 cycles per year * 1 year after menarche: >90 days for each menstrual cycle * Absence of menstruation at the age of 15 years or 3 years after menarche. Identification of phenotype groups: PHENOTYPE A: HA+ OD + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PCOM.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome
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.
Read the detailed description
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.
- Conditions
- Polycystic Ovary Syndrome, Adolescent Behavior, Diet Habit
- Being tested
- Low carbonhydrate diet
- Keywords
- phenotype, polycystic ovary syndrome, adolescents, low carbonhydrate diet
- Medical subject headings
- Polycystic Ovary Syndrome, Adolescent Behavior, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbonhydrate dietDietary supplement
Also called 0., 3.month
Each patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic.
| Study group | Role | What they receive |
|---|---|---|
| Phenotype A | PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM Receives: Dietary Supplement: Low carbonhydrate diet | |
| Phenotype B | PHENOTYPE B: HA+OD Receives: Dietary Supplement: Low carbonhydrate diet | |
| Phenotype C | PHENOTYPE C: HA+PCOM Receives: Dietary Supplement: Low carbonhydrate diet | |
| Phenotype D | PHENOTYPE D: OD+PCOM Receives: Dietary Supplement: Low carbonhydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
demographic datas on the study
Age
Measured: 3 months
Evaluation of demographic data
Smoking
Measured: 3 months
Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
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.
Measured: 3 months
Evaluation of clinical results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
waist circumference(centimeters)
Measured: 3 months
Evaluation of degree of hirsutism at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
degree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24)
Measured: 3 months
Hormone results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
prolactin (ng/mL)
Measured: 3 months
androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
androstenedione (mosm/kg)
Measured: 3 months
dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
dehydroepiandrosterone sulfate (DHEA-S) (μg/dL)
Measured: 3 months
TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
thyroid stimulating hormone (TSH) (mIU/mL)
Measured: 3 months
SHBG at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Hormone test results : sex hormone-binding globulin (SHBG)
Measured: 3 months
17-OH progesterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
17-OH progesterone (mIU/mL)
Measured: 3 months
Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
free and total testosterone (ng/mL)
Measured: 3 months
Lipid profile at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Lipid profile: Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL).
Measured: 3 months
Glucose at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
fasting blood glucose
Measured: 3 months
Evaluation of insulin resistance at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
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].
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start30 Sep 2024
- Primary completion7 Oct 2024
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mujde Can Ibanoglu, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Investigators
- Mujde Can Ibanoglu, Principal investigator, Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429618
- Sponsor's protocol ID
- 01/07 22.01.2024
- Acronym
- PCOS
- Status last verified
- Feb 2025
- First submitted
- 18 May 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joham AE, Pena AS. Polycystic Ovary Syndrome in Adolescence. Semin Reprod Med. 2022 Mar;40(1-02):e1-e8. doi: 10.1055/s-0042-1757138. Epub 2022 Sep 12.
PubMed 36096151Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.
PubMed 27664216
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06429618
- Acronym / sponsor ID
- PCOS / 01/07 22.01.2024
- Conditions
- Polycystic Ovary Syndrome, Adolescent Behavior, Diet Habit
- Keywords
- phenotype, polycystic ovary syndrome, adolescents, low carbonhydrate diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phenotype A | – | Dietary Supplement: Low carbonhydrate dietPHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM |
| Phenotype B | – | Dietary Supplement: Low carbonhydrate dietPHENOTYPE B: HA+OD |
| Phenotype C | – | Dietary Supplement: Low carbonhydrate dietPHENOTYPE C: HA+PCOM |
| Phenotype D | – | Dietary Supplement: Low carbonhydrate dietPHENOTYPE D: OD+PCOM |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will be conducted based on the 2018 ESHRE/ASRM guideline: 1. Oligo and/or anovulation* 2. Clinical and/or biochemical hyperandrogenism *Oligo and/or anovulation are defined as follows: * It is considered normal in the first year after menarche as part of the pubertal transition * Between 1-3 years after menarche: < 21 or > 45 days * 3 years after menarche - perimenopause: < 21 or > 35 days or < 8 cycles per year * 1 year after menarche: >90 days for each menstrual cycle * Absence of menstruation at the age of 15 years or 3 years after menarche. Identification of phenotype groups: PHENOTYPE A: HA+ OD + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PCOM.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbonhydrate dietAlso: 0., 3.monthEach patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic. | Dietary supplement | Phenotype A, Phenotype B, Phenotype C, Phenotype D |
Primary outcome
demographic datas on the study
Time frame: 3 months
Age
Evaluation of demographic data
Time frame: 3 months
Smoking
Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 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.
Time frame: 3 months
waist circumference(centimeters)
Evaluation of degree of hirsutism at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 3 months
degree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24)
Hormone results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 3 months
prolactin (ng/mL)
androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 3 months
androstenedione (mosm/kg)
dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 3 months
dehydroepiandrosterone sulfate (DHEA-S) (μg/dL)
TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 3 months
thyroid stimulating hormone (TSH) (mIU/mL)
SHBG at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 3 months
Hormone test results : sex hormone-binding globulin (SHBG)
17-OH progesterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 3 months
17-OH progesterone (mIU/mL)
Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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].
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 36096151Joham AE, Pena AS. Polycystic Ovary Syndrome in Adolescence. Semin Reprod Med. 2022 Mar;40(1-02):e1-e8. doi: 10.1055/s-0042-1757138. Epub 2022 Sep 12.
- Results publication: PubMed 27664216Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mujde Can Ibanoglu principal investigator
Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Adolescent Behavior, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demographic datas on the study (time frame: 3 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06429618, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.