Study on Metformin and Lifestyle Changes for Girls with Early Puberty and Overweight

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Metformin and lifestyle changes in young girls experiencing early puberty and who are overweight. Metformin is a medication commonly used to help control blood sugar levels and is being tested here for its potential to help with insulin sensitization, which means making the body more responsive to insulin, a hormone that helps control blood sugar. The study also includes a placebo, which is a substance with no active medication, to compare the effects of Metformin.

The purpose of the study is to understand how Metformin and lifestyle changes might affect the progression of puberty in these girls. The study will last for six months, during which participants will either receive Metformin or a placebo, and some will also participate in a lifestyle intervention. This intervention may include changes in diet and physical activity to see how these factors influence body composition and pubertal development. The main focus is on how these treatments affect bone age, which is a way to measure how quickly a child’s bones are maturing, as a marker of pubertal progression.

Throughout the study, researchers will monitor various aspects of the participants’ health, including changes in breast development, levels of sex hormones, and other metabolic markers. They will also assess body composition, fitness levels, blood pressure, heart rate, daily physical activity, and overall quality of life. The study aims to provide insights into how these interventions might help manage early puberty and its associated challenges in young girls.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, breast development, and body mass index (BMI).

2 initial assessment

An initial assessment is conducted to evaluate current health status, including breast development and hormone levels.

3 randomization

Participants are randomly assigned to receive either Metformin or a placebo. This process ensures that the study results are unbiased.

4 medication administration

Participants take Metformin or a placebo orally in the form of film-coated tablets. The dosage is 1000 mg, and the treatment lasts for 6 months.

5 lifestyle intervention

A lifestyle intervention is implemented, focusing on changes in body composition and physical activity. This intervention is conducted alongside the medication administration.

6 ongoing assessments

Throughout the study, regular assessments are conducted to monitor changes in bone age, breast development, sex hormones, and other health markers.

7 final assessment

At the end of the 6-month period, a final assessment is conducted to evaluate the effects of the treatment and lifestyle intervention on pubertal progression.

Who Can Join the Study?

Girls aged between 8 and 9.5 years old.
Breast development observed during a clinical examination, at least at stage 2 according to the Tanner scale. The Tanner scale is a way to measure physical development in children, adolescents, and adults.
A GnRH test showing stimulated LH levels greater than 5 IU/L or non-stimulated LH levels greater than 3 IU/L. The GnRH test checks how the body responds to a hormone that triggers puberty, and LH is a hormone involved in puberty.
Body Mass Index (BMI) greater than the 91st percentile or more than 1.34 standard deviations above average. BMI is a measure that uses height and weight to estimate body fat.
Has not yet started menstruating (premenarcheal).

Who Cannot Join the Study?

Girls who are not experiencing early puberty. Early puberty means starting puberty earlier than usual.
Girls who are not overweight. Overweight means having more body weight than is considered healthy for their age and height.
Girls who are not within the specific age range required for the study.
Girls who are not able to follow the study procedures for any reason.
Girls who have any medical conditions that might interfere with the study or make it unsafe for them to participate.
Girls who are taking medications that could affect the study results.
Girls who have participated in another clinical trial recently.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Sjaelland	Holbæk	Denmark
Hfhlpm Hncqudbr	Herlev	Denmark
Avfuis Uksqdsnecz Hctduvcs	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Metformin Hydrochloride

Metformin is a medication used in this study to help improve the body’s sensitivity to insulin. It is often used to manage blood sugar levels in people with type 2 diabetes, but in this trial, it is being used to see if it can affect pubertal progression in girls with overweight and early puberty. The goal is to determine if Metformin can influence bone age, which is a marker of pubertal maturation.

Lifestyle Intervention involves changes in daily habits, such as diet and physical activity, to improve overall health. In this study, the lifestyle intervention aims to alter body composition, which may impact pubertal progression. The intervention is designed to help participants achieve a healthier weight and improve their physical fitness, potentially affecting their bone age and pubertal development.

Investigated diseases:

Precocious Puberty – This condition occurs when a child’s body begins changing into that of an adult too soon. Typically, puberty starts between ages 8 and 13 in girls and 9 and 14 in boys. In precocious puberty, these changes occur before age 8 in girls and before age 9 in boys. The progression involves early development of secondary sexual characteristics, such as breast development in girls and testicular enlargement in boys. It can lead to a rapid growth spurt initially, but may result in shorter adult height due to early closure of growth plates. Hormonal changes are often responsible, and the condition can affect emotional and social development.

Overweight – This condition is characterized by having more body weight than is considered healthy for a given height. It is often measured using the Body Mass Index (BMI), which is a ratio of weight to height. Overweight can result from an imbalance between calories consumed and calories expended, leading to excess body fat accumulation. It can progress to obesity if not managed, increasing the risk of various health issues. Factors contributing to overweight include genetics, lifestyle choices, and environmental influences. It can affect physical health, self-esteem, and quality of life.

Trial ID:

2024-511009-50-00

NCT ID:

NCT05957991

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Metformin and Lifestyle Changes for Girls with Early Puberty and Overweight

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?