Study on Metformin Hydrochloride and Lifestyle Changes for Children and Adolescents with Obesity

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What is this study about?

This clinical trial is focused on studying the effects of the medication metformin in children and adolescents who have obesity. Obesity is a condition where excess body fat negatively affects a person’s health. The study will use two forms of metformin: Glucophage 500 mg film-coated tablets and Glucophage SR 500mg prolonged release tablets. Metformin is a medication commonly used to help control blood sugar levels, and in this study, it will be combined with lifestyle changes such as diet and exercise.

The purpose of the study is to compare the effects of metformin combined with lifestyle changes to lifestyle changes alone on the body mass index (BMI) of participants over a period of six months. BMI is a measure that uses height and weight to estimate body fat. Participants will be randomly assigned to one of three groups: one group will receive metformin extended release (XR) plus lifestyle changes, another group will receive metformin immediate release (IR) plus lifestyle changes, and the last group will follow lifestyle changes alone.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their BMI. The study aims to provide valuable information on how metformin, when combined with lifestyle changes, can affect weight management in young people with obesity. This research could help in developing better treatment strategies for managing obesity in children and adolescents.

1 randomization and group assignment

Upon joining the study, you will be randomly assigned to one of three groups. This means you will either receive metformin extended release (XR) with lifestyle changes, metformin immediate release (IR) with lifestyle changes, or lifestyle changes alone. This process is random to ensure fairness and accuracy in the study results.

2 medication administration

If you are assigned to a group receiving medication, you will take metformin orally. The dosage and frequency will depend on whether you are in the extended release or immediate release group. The study will provide specific instructions on how to take your medication.

3 lifestyle changes

All participants, regardless of group assignment, will be guided to make specific lifestyle changes. These changes may include adjustments to diet and physical activity. Detailed guidance will be provided to help you implement these changes effectively.

4 regular check-ups

Throughout the 6-month study period, you will attend regular check-ups. These visits are important to monitor your health and the effects of the treatment. During these visits, various measurements and tests will be conducted, such as blood pressure, blood tests, and other health assessments.

5 end of treatment evaluation

At the end of the 6-month period, a final evaluation will be conducted. This will include a comprehensive assessment of your health and any changes in your body mass index (BMI). The results will help determine the effectiveness of the treatment you received.

Who Can Join the Study?

Signed informed consent before any study-specific procedures. This means you agree to participate after understanding the study details.
Must be a boy or girl aged 6 to less than 17 years and 3 months at the time of signing the informed consent.
Body weight must be at least 40 kg (about 88 pounds).
Must have obesity as defined by a Body Mass Index Standard Deviation Score (BMI-SDS) greater than 2.0 according to the World Health Organization (WHO).
Body weight should be stable for the past 90 days before the first screening visit, meaning less than 5 kg (about 11 pounds) of weight change, whether measured or self-reported.
If you are a girl who can have children: You must not be sexually active or must use effective birth control methods and have negative pregnancy tests. Effective birth control methods include:
- Combined hormonal contraception (like pills, patches, or rings) that stops ovulation.
- Progestogen-only hormonal contraception (like pills, injections, or implants) that stops ovulation.
- Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
- Bilateral tubal occlusion (a permanent method of birth control).
- Partner has had a vasectomy (a permanent method of birth control for men).
- Sexual abstinence, meaning not having heterosexual intercourse during the study period. The reliability of this method should be considered based on your lifestyle.

Who Cannot Join the Study?

Patients who are not children or adolescents.
Patients who do not have obesity.
Patients who are not willing to follow the lifestyle changes required by the study.
Patients who are unable to take the medication metformin extended release (XR).
Patients who have medical conditions that could interfere with the study results.
Patients who are currently participating in another clinical trial.
Patients who have a history of allergic reactions to the study medication.
Patients who are pregnant or breastfeeding.
Patients who have a history of substance abuse.
Patients who have a serious mental health condition that is not well controlled.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Dalarna	Falun	Sweden
Updwdio Udmstcsusd Hilzepoc	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	09.09.2021

Trial locations

Investigated drugs:

Metformin Hydrochloride

Metformin Extended Release (XR) is a medication used to help manage weight in children and adolescents with obesity. It works by helping the body use insulin more effectively, which can lead to better control of blood sugar levels and potentially aid in weight loss. In this trial, it is combined with lifestyle changes, such as diet and exercise, to see if it can improve the Body Mass Index (BMI) of participants over six months.

Metformin Immediate Release (IR) is another form of the same medication used for managing weight in young people with obesity. Like the extended-release version, it helps the body use insulin better, which can help control blood sugar and support weight loss. This version is also used alongside lifestyle changes to evaluate its effect on the BMI of participants over the course of the study.

Investigated diseases:

Obesity

Obesity in Children and Adolescents – Obesity in children and adolescents is a condition characterized by excessive body fat that negatively affects a child’s health or well-being. It is typically identified using the Body Mass Index (BMI), which is adjusted for age and sex in children. As the condition progresses, it can lead to various health issues, including increased blood pressure, insulin resistance, and abnormal cholesterol levels. Over time, obesity can also contribute to the development of type 2 diabetes, liver disease, and orthopedic problems. The condition can affect physical health, social and emotional well-being, and self-esteem. It often requires long-term lifestyle changes to manage effectively.

Trial ID:

2024-517787-29-00

Protocol code:

MINT

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Metformin Hydrochloride and Lifestyle Changes for Children and Adolescents with Obesity

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?