A study with lifestyle intervention and study medication compared to onlylifestyle intervention in children and adolescents with obesity to exploredifferences between groups with regard to change in BMI

Phase 1

• Conditions: Children and Adolscents with obesity; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-003940-61-SE
• Lead Sponsor: ppsala county council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-20
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Signed informed consent prior to any study-specific procedures.
2.Males or females of age 6 to less than 17 years and 3 months at the time of signing informed consent.
3.Body weight = 40 kg.
4.Obesity (BMI-SDS >2.0) according to WHO.
5.Stable body weight during previous 90 days before screening Visit 1 (< 5kg measured or self-reported weight change).
6.If female of childbearing potential: Not sexually active or usage of adequate anticonception and having negative pregnancy tests. Methods that can achieve a failure rate of less than 1% per year (Pearl index <1), when used consistently and correctly, are considered as highly effective birth control methods.
Such methods include:
•Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal.
•Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable.
•Intrauterine device (IUD).
•Intrauterine hormone-releasing system (IUS).
•Bilateral tubal occlusion.
•Vasectomised partner
•Sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle).

Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known syndromal obesity (e.g. Prader-Willi syndrome, Bardet-Biedl syndrome or Laurence-Moon syndrome).
2.Pregnancy or lactation.
3.Indigestion-causing diseases
4.Severe gastrointestinal disease, as judged by investigator.
5.Total or partial gastric or small intestine resection.
6.Type 1 diabetes mellitus.
7.Kidney disease or renal dysfunction, acute or chronic (eGFR <60ml/min/1,73m2).
8.Hypo-/hyperthyroidism, unless stable treatment.
9.Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by investigator.
10.Severe sleep apnea, as judged by investigator.
11.Chronic disease, as judged by investigator
12.Metformin treatment within 3 months prior to screening or concomitant medication influencing blood glucose (e.g. metformin and acarbose), influencing other parameters of metabolic syndrome (e.g. orlistat) or interfering with the investigational medicinal product.
13.Steroid treatment (oral or injected).
14.Antidepressants that can lead to weight gain, as judged by investigator.
15.Unstable treatment for neuropsychiatric disorders such as ADHD/ADD, and/or treatment started within 3 months prior to screening visit
16.Known hypersensitivity to metformin or any of the excipients.
17.Language difficulties, impaired mental ability or not willing to understand or comply with the study procedures
18.Participation in another clinical study involving an Investigational Medicinal Product (IMP) within three months prior to screening.
19.Subject from the same household participating in this trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified