EUCTR2015-005585-32-DK进行中（未招募）1 期
Synergy effect of the appetite hormone GLP-1 (LiragluTide) and Exercise on maintenance of weight loss and health after a low calorie diet - the S-LiTE randomized trial - S-LiTE
Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen0 个研究点目标入组 222 人开始时间: 2016年5月11日最近更新:
适应症
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
- 222
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
- •BMI > 32 and < 43 (kg/m2), age > 18 and < 65 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 222
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l)
- •Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
- •Severe renal impairment (creatinine clearance (GFR) <30 mL/min)
- •Severe hepatic impairment
- •Inflammatory bowel disease
- •Diabetic gastroparesis
- •Chronic obstructive lung disease
- •Psychiatric disease, a history of major depressive or other severe psychiatric disorders
- •The use of medications that cause clinically significant weight gain or loss
- •Previous bariatric surgery
- •A history of idiopathic acute pancreatitis
- •A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- •Osteoarthritis which is judged to be too severe to manage the exercise programme. As intended per study design the intervention will include a 5% weight loss prior to randomization, thus it is expected that possible participants with mild form of osteoarthritis will be able to manage exercise prescriptions.
- •Pregnancy, expecting pregnancy or breast feeding. If a study participant is in doubt whether she could be pregnant, a urine pregnancy test is performed. Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice). Adequate contraception must be used throughout the study period and at least 65 hours after discontinuation of trial medication (65 hours corresponds to 5 times the half-life of Saxenda). Allergy to any of the ingredients/excipients.
- •Allergy to any of the ingredients/excipients of the study medication: liraglutide, disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid, sodium hydroxide
- •Regular exercise training at high intensity (e.g. spinning) >2 hours per week.
研究者
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