Study on Slowing Advanced Puberty in Girls Using Metformin, Pioglitazone, and Spironolactone

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What is this study about?

This clinical trial is focused on studying girls with advanced puberty and accelerated bone maturation, as well as those with Polycystic Ovary Syndrome (PCOS). The treatment being tested is a medication called SPIOMET, which is a combination of three active substances: metformin, pioglitazone, and spironolactone. These substances are commonly used to manage conditions related to insulin resistance and hormonal imbalances. The purpose of the study is to determine if this combination can help slow down the rapid maturation process in young girls who have experienced low birth weight and high weight gain after birth.

Participants in the study will be randomly assigned to receive either the SPIOMET treatment or a placebo. The study will last for a period of 12 months, during which the participants will take the medication in tablet form. Throughout the study, various health parameters will be monitored, including bone development, weight, height, and hormone levels. The study aims to observe any changes in these parameters to assess the effectiveness of the treatment.

In addition to monitoring physical changes, the study will also evaluate the safety of the treatment by checking blood tests and other health markers. The goal is to ensure that the treatment is not only effective but also safe for the participants. The study will provide valuable insights into managing conditions related to early puberty and PCOS in young girls, potentially leading to better treatment options in the future.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria such as age, birth weight, and pubertal development stage.

A physical examination is conducted, including measurements of height, weight, and body mass index (BMI). Blood samples may be taken to assess various health markers.

2 medication administration

Participants receive the study medication, spiomet, which is a combination of metformin, pioglitazone, and spironolactone. The medication is administered orally in tablet form.

The dosage and frequency of administration are determined by the study protocol and are explained during this step.

3 regular follow-up visits

Regular follow-up visits are scheduled to monitor progress and assess the effects of the medication. These visits include physical examinations and may involve additional blood tests.

Participants are asked about any side effects or changes in health status. Adherence to the medication regimen is also reviewed.

4 imaging and assessments

Imaging tests, such as X-rays of the hand and wrist, are performed to evaluate bone age advancement. This helps in assessing the primary endpoint of the study.

Additional assessments may include MRI scans to analyze abdominal and liver fat distribution.

5 final evaluation

At the end of the study period, a final evaluation is conducted. This includes a comprehensive review of all collected data and health assessments.

Participants are informed about the study’s findings and any implications for their health.

Who Can Join the Study?

Girls aged between 8.0 and 9.5 years at the start of the study.
Born with a low birth weight for their gestational age, which means they were smaller than most babies born at the same number of weeks of pregnancy.
Have a high body mass index (BMI) for their age, which means they weigh more than most children their age.
Experiencing advanced puberty, which means they have started developing breasts (Tanner stage 2) between the ages of 7.7 and 9.3 years, and this development has been progressing for at least 2 months.
Of White ethnicity.
Born at term or late preterm, meaning they were born between 34 and 42 weeks of pregnancy.
Height at the first visit is between the 3rd and 97th percentile for their age and pubertal stage, meaning their height is within the normal range for their age and development.
Parents or legal guardians must provide written informed consent, which means they agree to let their child participate in the study after being fully informed about it.

Who Cannot Join the Study?

Girls who are not experiencing advanced puberty (a stage of development when a child’s body begins to change into an adult body).
Girls who do not have accelerated bone maturation (when bones develop faster than normal).
Girls who do not have Polycystic Ovary Syndrome (PCOS) (a condition that affects a woman’s hormone levels).
Girls who do not have a history of low prenatal weight (low weight before birth).
Girls who do not have a history of high postnatal weight (high weight after birth).

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	02.12.2022

Trial locations

Investigated drugs:

Spiomet is a combination of medications used in this clinical trial to help slow down the rapid physical development in young girls who are going through puberty earlier than usual. This combination works by targeting different pathways in the body to reduce the amount of fat stored in places where it shouldn’t be, which can happen when a girl has a low birth weight but gains a lot of weight after birth. By doing this, Spiomet aims to help manage the body’s ability to store fat safely and reduce the speed of maturation.

Polycystic Ovary Syndrome (PCOS) – Polycystic Ovary Syndrome is a hormonal disorder common among women of reproductive age. It is characterized by irregular menstrual periods, excess androgen levels, and polycystic ovaries. The condition often leads to the development of small cysts on the ovaries. As the syndrome progresses, women may experience symptoms such as weight gain, acne, and thinning hair. The hormonal imbalance can also lead to difficulties with fertility. Over time, PCOS can contribute to long-term health issues like type 2 diabetes and heart disease.

Trial ID:

2024-518675-55-00

Protocol code:

MINI-SPIOMET

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Slowing Advanced Puberty in Girls Using Metformin, Pioglitazone, and Spironolactone

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Who Can Join the Study?

Who Cannot Join the Study?