NCT04781998已完成4 期
Is Pharmacological Treatment With the Glucagon-like Peptide-1 Receptor Agonist Liraglutide 3mg (Saxenda®) Once-daily a Viable Treatment for Weight Management in Forensic Psychiatry Patients? A Feasibility Study.
Anders Fink-Jensen, MD, DMSci1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The primary endpoint is the number of "completers"
研究概览
简要总结
An open-label, multi-centre, 26-weeks clinical feasibility study. The objective is to explore whether Saxenda could be a feasible choice in the treatment of overweight, obesity and weight-related medical problems, in patients diagnosed with a severe mental illness and hospitalized at a forensic department in Denmark. We wish to determine the viability of the daily Saxenda®-injection treatment in this specific patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed oral and written consent
- •Diagnosed with a mental illness according to the criteria of ICD10
- •Hospitalised at a forensic psychiatric department during the full inclusion period
- •Age 18 years to 65 years (both included)
- •BMI ≥27 kg/m2 with one or more weight-related comorbidities (sleep apnea, hypertension (BT ≥ 140/90 mmHg with no antihypertensive treatment. BT ≥ 130/80 mmHg with antihypertensive treatment), dyslipidaemia (LDL cholesterol ≥ 3 mmol/L), pre-diabetes (HbA1c 39-47 mmol/mol) or type 2 diabetes (HbA1c ≥ 48 mmol/mol)) or BMI ≥30 kg/m2
排除标准
- •Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in "Informationsbekendtgørelsen § 10").
- •Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant
- •Women who are not willing to use an adequate contraceptive considered as highly effective (IUD or hormonal contraception during the full length of the study
- •Impaired hepatic function (plasma liver transaminases >2 times the upper normal limit)
- •Impaired renal function (serum creatinine >150 μmol/l and/or macroalbuminuria)
- •Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times the upper normal limit)
- •Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
- •Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
- •Any condition that the investigator feels would interfere with trial participation
- •Use of weight-lowering pharmacotherapy within the preceding 3 months
- •Type 1 diabetes
- •Patients treated with insulin
- •Patients treated with other GLP-1 receptor agonist medicines
- •Known allergy to liraglutide or any of the ingredients in Saxenda®
研究组 & 干预措施
liraglutide 3 mg (Saxenda®) once-daily
Experimental
干预措施: liraglutide 3 mg (Saxenda®) once-daily (Drug)
结局指标
主要结局
The primary endpoint is the number of "completers"
时间窗: 26 weeks
Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%.
次要结局
- Changes in body weight(26 weeks)
- Reason(s) for drop-out(26 weeks)
- HbA1c(26 weeks)
- blood pressure(26 weeks)
- heart rate(26 weeks)
- FIB-4 score(26 weeks)
- lipid profile(26 weeks)
研究者
Anders Fink-Jensen, MD, DMSci
Professor
Psychiatric Centre Rigshospitalet
研究点 (1)
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