EUCTR2015-005163-16-DK进行中（未招募）1 期
Effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis. A randomised, double blind, placebo-controlled, parallel group, single-centre trial
The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark0 个研究点目标入组 150 人开始时间: 2016年3月2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
- 150
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
- •Informed consent obtained
- •Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3)
- •Age = 18 years and < 75 years
- •Body mass index (BMI) = 27 kg/m2
- •Stable body weight during the previous 3 months (< 5 kg self-reported weight change)
- •Motivated for weight loss
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •On-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months)
- •Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
- •Current use or use within three months before this trial of GLP-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine
- •Use of opioids or similar strong analgesics
- •Type 1 diabetes
- •Type 2 diabetes treated with glucose-lowering drugs other than metformin
- •Alloplasty in target knee joint (see section 6.3)
- •End stage disease in target knee joint (Kellgren-Lawrence grade 4)
- •Pregnancy or insufficient anti-conception therapy for female fertile patients
- •Breast-feeding
- •Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x above upper normal range (UNR)
- •Surgery scheduled for the trial duration period, except for minor surgical procedures
- •Surgical procedures such as arthroscopy or injections into a knee within 3 months prior to enrolment
- •Previous surgical treatment for obesity (excluding liposuction >1 year before trial entry)
- •Thyroid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
- •Obesity secondary to endocrinologic or eating disorders or to treatment with medicinal products that may cause weight gain
- •Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- •Inflammatory bowel disease
- •Congestive heart failure, New York Heart Association (NYHA) class III-IV
- •Diabetic gastroparesis
- •History of or current diagnosis of pancreatitis (acute and/or chronic) or pancreatic cancer
- •History of cancer with the exception of in-situ malignancies of the skin or cervix uteri
- •History of major depressive disorder, a PHQ-9 (Patient Health Questionnaire-9) score of more than 15, or a history of other severe psychiatric disorders or diagnosis of an eating disorder
- •Subjects with a lifetime history of a suicide attempt or history of any suicidal behaviour within the past month before entry into the trial
- •Inability to speak Danish fluently
- •A mental state impeding compliance with the program
研究者
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