ACTRN12621001434886招募中4 期
Open label randomised controlled trial of the glucagon like peptide-1 receptor agonist (GLP1RA) semaglutide vs usual care for metabolic risk in people with psychosis.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •To be eligible for the study participants must:
- •Be aged 18-65 years inclusive
- •Be a client registered with SESLHD MHS with a documented psychotic illness
- •Have a BMI > 25
- •Have the ability to provide informed consent
- •Currently be prescribed antipsychotic therapy (clozapine or olanzapine) and have been for at least 6 months.
排除标准
- •Exclusion criteria for the study include people with the following conditions:
- •A personal or family history of medullary thyroid cancer.
- •Substance misuse or dependence except nicotine
- •Impaired liver function as indicated by lfts > 2 times upper limit of normal
- •Impaired pancreatic function as indicated by abdominal pain and a raised lipase, a history of pancreatitis or history of cancer of pancreas. Patients will be asked if they have abdominal pain. Patients with abdominal pain will be invited to have a blood lipase test irrespective of their participation in the trial. Those who consent and have a normal lipase will be included. Those who have an abnormal lipase will be excluded and referred to an emergency department
- •Unstable angina or New York heart association (nyha) class iii or iv cardiac failure within the last 12 months
- •Uncontrolled hypertension (sbp>180mm; dbp>110mm measured after 10 minutes rest)
- •Any condition the investigators feel would interfere with study participation and completion
- •Diabetes, including any person receiving insulin, sglt2 inhibitor or a gliptin or sulphonylurea. or who have HBA1c > 6.5 or fasting glucose >6.9mmol/L (and who therefore meet criteria for Type 2 Diabetes) will be excluded.
- •Females who are pregnant or planning to become pregnant during the period of administration of the study medication
- •Not maintained a stable weight (defined as a greater than 5% weight change since last weight one month earlier)
- •Or those currently receiving the following treatments:
- •Any investigational drug within the last 3 months
- •Pharmacotherapy for weight loss within the last 3 months
- •Metformin (and not on a stable dose < 3 months)
- •Oral medications requiring rapid gastro-intestinal absorption
- •Hormone therapy with the exception of contraceptive hormones. Clients who are stable on thyroxine and without a history of thyroid cancer may be considered for the study.
- •Additionally potential participants will be excluded if their treating psychiatrist believes they may be unable to consent to participate in the trial, or who are vulnerable to suasion so that it is unlikely that informed consent can be properly obtained, or those who become so during the study.
研究者
相似试验
已完成
4 期
A comparative study of the effects of Liraglutide and Acarbose on glycaemic control, weight and Health Related Quality Of Life (HRQOL) in Overweight type 2 Diabetic patients on Oral Hypoglycaemic Agents (OHAs) and high doses of insulin.ISRCTN47355247West Wales Hospital (UK)66
已完成
不适用
A randomised controlled trial of oral glucose for pain relief in 2 month old infants undergoing immunisatioimmunisation pain in infantsPublic Health - Health promotion/educationAnaesthesiology - AnaestheticsACTRN12610000069055niversity of Technology Sydney120
尚未招募
3 期
A study on the effect of Ayurvedic complementary food.CTRI/2023/06/053488il
尚未招募
3 期
A prospective, randomised, open label trial on the effect of metformin on in-vitro fertilisation outcome in women with polycystic ovary syndromePolycystic ovary syndromeReproductive Health and Childbirth - Fertility including in vitro fertilisationMetabolic and Endocrine - Other metabolic disordersInfertilityACTRN12609000510246Fertility Society of Australia124
招募中
3 期
A Randomised Controlled Trial of the efficacy and safety of an Inhaled Corticosteroid and Long Acting Beta Agonist reliever therapy regimen in preschool children with mild asthma/recurrent wheeze.ACTRN12623000670673The University of Auckland280