2024-517787-29-00已完成2 期
Metformin Intervention in children and adolescents with obesity. A parallel, three arms, randomized, 6 months, multi-center study with metformin extended release (XR) plus lifestyle or metformin immediate release (IR) plus lifestyle or lifestyle alone.
Region Uppsala2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年10月8日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- BMI-SDS (according to WHO).
研究概览
简要总结
To compare the effect between metformin extended release (XR) plus lifestyle, and lifestyle alone on the BMI-SDS change, from baseline to the 6 months visit at end of treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study-specific procedures.
- •Males or females of age 6 to less than 17 years and 3 months at the time of signing informed consent.
- •Body weight ≥ 40 kg.
- •Obesity (BMI-SDS >2.0) according to WHO.
- •Stable body weight during previous 90 days before screening visit 1 (< 5kg measured or self-reported weight change).
- •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).
排除标准
- •Known syndromal obesity (e.g. Prader-Willi syndrome, Bardet-Biedl syndrome or Laurence-Moon syndrome).
- •Severe sleep apnea, as judged by investigator.
- •Chronic disease, as judged by investigator.
- •Any 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 from 3 months prior to screening until the end of the treatment period at visit
- •Steroid treatment (oral or injected).
- •Antidepressants that can lead to weight gain, as judged by investigator.
- •Unstable treatment for neuropsychiatric disorders such as ADHD/ADD, and/or treatment started within 3 months prior to screening visit.
- •Known hypersensitivity to metformin or any of the excipients.
- •Language difficulties, impaired mental ability or not willing to understand or comply with the study procedures.
- •Participation in another clinical study involving an Investigational Medicinal Product (IMP) within three months prior to screening.
- •Subject from the same household participating in this trial.
- •Pregnancy or lactation.
- •Indigestion-causing diseases.
- •Severe gastrointestinal disease, as judged by investigator.
- •Total or partial gastric or small intestine resection.
- •Type 1 diabetes mellitus.
- •Kidney disease or renal dysfunction, acute or chronic (eGFR <60ml/min/1,73m2 ).
- •Hypo-/hyperthyroidism, unless stable treatment.
- •Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by investigator.
结局指标
主要结局
BMI-SDS (according to WHO).
BMI-SDS (according to WHO).
次要结局
- 7. Triglycerides, Total cholesterol, High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), SBP and DBP.
- 1 and 3: BMI-SDS (according to WHO).
- 2. Adverse Events, vital signs (systolic and diastolic blood pressure (SBP and DBP) and heart rate), physical examination, fP-glucose, ALAT, creatinine, lactate, cobalamin, clinical chemistry, haematology and urine analysis and plasma metformin concentration.
- 4. Plasma and urine concentration of metformin (PK), area under the curve (AUC), BMI-SDS (according to WHO).
- 5. Demographics, tanner stage, anthropometrics and growth chart. Plasma and urine concentration of metformin (PK), area under the curve (AUC) and BMI-SDS (according to WHO).
- 6. Glucose and insulin at fasting and during OGTT. Insulin secretion and sensitivity derived from OGTT. HbA1c.
- 8. Creatinine, Cystatin C/GFR, Alanine Aminotransferase (ALAT), Gamma Glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LD) and Bilirubin.
- 9. Hs-CRP.
- 10. IGF-1, SHBG, FSH, LH, Testosterone and Estrogen.
- 11. Anthropometrics, waist- and hip circumference (including ratio), and sagittal abdominal diameter (SAD). Bioimpedance, indirect calorimetry and skin fold measurement will be performed at selected sites
- 12. Questionnaires: Food Frequency (FFQ), Regular meals, Portion Size, Physical Activity, Medipal®.
- 13. PedsQL™.
研究者
Obesity Unit f Children&Adolescents
Scientific
Region Uppsala
研究点 (2)
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