EUCTR2015-001628-45-SE进行中（未招募）1 期
A parallel, double-blinded, randomized, 6 months, two arms study with lifestyle intervention and exenatide 2 mg once weekly or lifestyle intervention and placebo in adolescents with obesity to explore differences between groups with regard to change in BMI SDS (according to WHO). - Combat-JUDO
Dep. of Medical Cell Biology Uppsala University0 个研究点目标入组 44 人开始时间: 2015年7月27日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed informed consent prior to any study-specific procedures.
- •2.Males or females of age 10-18 years and 7 months.
- •3.Obesity (BMI SDS > 2.0 or age-adapted BMI > 30 kg/m2), according to WHO.
- •4.Not sexually active or usage of adequate anticonception. Female subjects must also have 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 (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •ointravaginal
- •otransdermal
- •Progestogen-only hormonal contraception associated with inhibition of ovulation:
- •oinjectable
- •oimplantable
- •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 of the subject).
- •5.Ability to understand and comply with the requirements of the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 34
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known syndromal obesity, such as Prader-Willi syndrome, Laurence-Moon syndrome or Bardet-Biedl syndrome.
- •2.Pregnancy or lactation.
- •3.Indigestion-causing diseases.
- •4.Severe gastrointestinal disease.
- •5.Total or partial gastric or small intestine resection.
- •6.Type 1 or Type 2 diabetes mellitus.
- •7.Kidney disease (acute or chronic, according to physician (Creatinin/Urea/Cystatin-C for Schwartz Calculation)).
- •8.Hypo-/Hyperthyroidism, unless under stable treatment.
- •9.Severe Vitamin D insufficiency, unless under stable treatment.
- •10.Abnormal QT interval.
- •11.Clinically significant abnormal laboratory values, e.g.
- •Triglycerides > 400 mg/dl (Salzburg) or > 4,5 mmol/L (Uppsala),
- •Amylase > 300 U/L (Salzburg) or > 5,1 µkat/L (Uppsala),
- •Lipase > 180 U/L (Salzburg) or > 15 µkat/L (Uppsala) or
- •Calcitonin > 11.7 pg/ml (Salzburg) or > 3,4 pmol/L (Uppsala) for females and > 17 pg/ml (Salzburg) or > 5,0 pmol/L (Uppsala) for males.
- •12.Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by the investigator.
- •13.Severe sleep apnea (defined clinically).
- •14.Chronic diseases, as judged by the investigator.
- •15.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.
- •16.Steroid treatment (oral or injected).
- •17.Concomitant medication addressing attention disorders.
- •18.Antidepressants that can lead to weight gain, as judged by the investigator.
- •19.Hypersensitivity to exenatide or to any of the excipients.
- •20.Pacemaker or metal implant that may interfere with Magnetic Resonance Imaging (MRI).
- •21.Claustrophobia.
- •22.Current or prior (within 3 months) participation in another clinical study involving an Investigational Medicinal Product (IMP).
- •23.A personal or family history of Medullary Thyroid Carcinoma (MTC)
- •24.A personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
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