EUCTR2017-002998-20-GB进行中（未招募）1 期
Effectiveness and cost of integrating a protocol with use of liraglutide 3.0mg into an obesity service (STRIVE Study) - STRIVE Study
niversity of Leicester0 个研究点目标入组 384 人开始时间: 2018年5月15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
- 384
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
- •To be considered eligible to participate in this study, a patient must:
- •be aged between 18-75 years old (inclusive)
- •understand written and spoken English
- •be able to give informed consent
- •have a BMI =35 kg/m2
- •have been referred to the Tier 3 service in one of the participating sites
- •have a stable body weight (less than 5kg self-reported change during the previous 12 weeks)
- •have at least one of prediabetes, diabetes, hypertension, and/or obstructive sleep apnoea, as defined below:
- •-prediabetes (defined as established diagnosis of impaired fasting glycaemia (IFG) from GP and/or established diagnosis of impaired glucose tolerance (IGT) from GP and/or HbA1C 42-47 mmol/mol (6-6.4%) without glucose lowering medications, at a blood test during the last 6 months)
- •-diabetes (defined as established diagnosis of Type 2 diabetes from GP and/or HbA1C =48 mmol/mol (>6.5%) at a blood test during the last 6 months] and/or being treated with any combination of lifestyle, metformin, sulphonylureas, Thiazolidinediones (TZDs) or SGLT-2)
- •-hypertension treated (defined as being on antihypertensive treatment with or without a diagnosis of hypertension from GP) or untreated (defined as Systolic Blood Pressure =140 mmHg at two consecutive visits at the Tier 3 clinic),
- •-obstructive sleep apnoea (on CPAP or established diagnosis of Apnoea Hypopnoea Index =15 at sleep studies during the last 12 months).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
排除标准
- •Patients who have met any of the following criteria will be excluded from the study:
- •Diagnosis of Type 1 diabetes
- •T2DM with treatment on DPP-IV or insulin currently
- •Treatment with GLP-1 receptor agonists in the past or currently
- •Treatment with anti-obesity drugs within 12 weeks prior to randomisation
- •eGFR =30ml/min/1.73m2 on serum testing over the last 26 weeks
- •Females referred to the clinic because of fertility problem
- •Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using or willing to use adequate contraceptive methods (as described in Section 8.3.1
- •Have terminal illness
- •Are not primarily responsible for their own care
- •Any other significant disease or disorder which in the opinion of the investigator, may either put the participants at risk or may influence the result of the study or the participant’s ability to participate
- •Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone >6 mIU/litre or <0.4 mIU/litre
- •Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)
- •Personal history of non-familial medullary thyroid carcinoma
- •History of chronic pancreatitis or idiopathic acute pancreatitis
- •Amylase or lipase levels three times higher than the upper normal range
- •Obesity induced by other endocrinologic disorders (e.g. Cushing’s Syndrome)
- •Current or history of treatment with medications that may cause significant weight gain, within 12 weeks prior to randomisation, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic and mood stabilizers (e.g. clozapine, olanzapine, valproic acid and its derivatives, and lithium)
- •Initiation of antidepressants during the last 12 weeks
- •Previous surgical treatment for obesity (excluding liposuction if performed >1 year before trial entry)
- •History of other severe psychiatric disorders
- •History of known or suspected abuse of alcohol and/or narcotics
- •History of major depressive episode during the last 2 years
- •Simultaneous participation in other clinical trials of investigational drugs, lifestyle or physical activity interventions. Patients will only be able to take part following participation in a previous clinical trial after a wash-out period of 16 weeks.
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