## Protocol Section
### Identification Module
**NCT ID:** NCT06429618

**Acronym:** PCOS

**Brief Title:** Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet

**Official Title:** Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome

#### Organization Study ID Info
**ID:** 01/07 22.01.2024
#### Organization
**Class:** OTHER
**Full Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

**Investigator Full Name:** Mujde Can Ibanoglu

**Investigator Title:** Assoc. Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 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 Module

**Conditions:**

- Polycystic Ovary Syndrome

- Adolescent Behavior

- Diet Habit

**Keywords:**

- phenotype

- polycystic ovary syndrome

- adolescents

- low carbonhydrate diet

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM

**Intervention Names:**

- Dietary Supplement: Low carbonhydrate diet

**Label:** Phenotype A

#### Arm Group 2

**Description:** PHENOTYPE B: HA+OD

**Intervention Names:**

- Dietary Supplement: Low carbonhydrate diet

**Label:** Phenotype B

#### Arm Group 3

**Description:** PHENOTYPE C: HA+PCOM

**Intervention Names:**

- Dietary Supplement: Low carbonhydrate diet

**Label:** Phenotype C

#### Arm Group 4

**Description:** PHENOTYPE D: OD+PCOM

**Intervention Names:**

- Dietary Supplement: Low carbonhydrate diet

**Label:** Phenotype D

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Phenotype A

- Phenotype B

- Phenotype C

- Phenotype D

**Description:** 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.

**Name:** Low carbonhydrate diet

**Other Names:**

- 0.

- 3.month

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Age, smoking, physical activity status, weight, height, body mass index (weight (kilogram)/height\*2 (meter2)), waist circumference(centimeters), degree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24) were obtained from hospital records. 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.

**Measure:** Evaluation of clinical outcomes at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

**Time Frame:** 3 months

**Description:** Collection of serum samples: C-reactive protein (CRP) (mg/dL), complete blood analysis, sex hormone-binding globulin (SHBG), free and total testosterone (ng/mL), 17-OH progesterone (mIU/mL), prolactin (ng/mL), thyroid stimulating hormone (TSH) (mIU/mL), androstenedione (mosm/kg), dehydroepiandrosterone sulfate (DHEA-S) (μg/dL), Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL), fasting blood glucose, 50 g screening test values were analyzed in the biochemistry laboratory. Serum levels of DHEA-S, 17-OH-progesterone and testosterone were measured using the radiometric method. The blood count was measured using the Sysmex/XN-1000 (2016) blood analyzer. Serum levels of DHEA-S, 17-OH-progesterone and free testosterone were measured using a radiomonassay. Serum lipid and glucose levels were analyzed using the AU680 Chemistry System (Beckman Coulter, Fullerton, CA, USA).

**Measure:** Evaluation of biochemical outcomes at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

**Time Frame:** 3 months

**Description:** 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. \[HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405\].

**Measure:** Evaluation of insulin resistance at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 24 Years

**Minimum Age:** 12 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Drmujdecan@gmail.com

**Name:** Mujde Can Ibanoglu

**Phone:** 05323089488

**Role:** CONTACT

**Contact 2:**

**Email:** ustunyaprak@yahoo.com

**Name:** Yaprak Engin-Ustun

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.

**Name:** Mujde Can Ibanoglu

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 36096151

**Citation:** Bozdag 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.

**PMID:** 27664216

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010048

- Term: Ovarian Cysts

- ID: D000003560

- Term: Cysts

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M13970

- Name: Polycystic Ovary Syndrome

- Relevance: HIGH

- As Found: Polycystic Ovary Syndrome

- ID: M6765

- Name: Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M12971

- Name: Ovarian Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011085

- Term: Polycystic Ovary Syndrome

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-31
