ISRCTN10203365进行中（未招募）2 期
Investigating and optimising physical function with weight loss: a multi-arm open-label adaptive platform trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
- 主要终点
- Physical function measured using meters covered during the incremental shuttle walk test at baseline and week 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Master Inclusion Criteria:
- •BMI of = 30.0 kg/m2 OR2, BMI = 27 to <30.0 kg/m2 (with at least one of the following weight-related comorbidities or risk factors: hypertension, dyslipidaemia, prevalent or previous cardiovascular disease (e.g., stable heart failure), elevated HbA1c (5.7 - 9.9%), polycystic ovary syndrome, history of gestational diabetes, taking hypertensive medication or taking lipid-lowering medication.
- •Weight stable for at least 90 days before screening (self-reported < 5kg change in body weight)
- •Able and willing to give informed consent
- •Able to understand written and spoken English
- •Able to walk without assistance Younger age cohort Additional criteria that outline inclusion for the younger cohort: 18 to 44 years of age at screening (Visit 0), inclusiveMiddle-to-older age cohort Additional criteria that outline inclusion for the middle-to-older cohort: 45 to 75 years of age at screening (Visit 0), inclusiveLong COVID cohort Additional criteria that outline inclusion for the long COVID cohort:
- •18 to 75 years of age at screening (Visit 0), inclusive
- •Clinical diagnosis of long COVID with ongoing care, assessed by a long COVID service.
- •Offered long COVID rehabilitation or >6 months post-completion of long COVID rehabilitation. Exception from the master inclusion/exclusion for the long COVID cohort (these criteria do not apply to this cohort):
- •BMI = 27 to <30.0 kg/m2 (with at least one of the following weight-related comorbidities or risk factors: hypertension, dyslipidaemia, cardiovascular disease (e.g., stable heart failure), elevated HbA1c (5.7 - 9.9%), polycystic ovary syndrome, history of gestational diabetes, taking hypertensive medication or taking lipid-lowering medication.
- •Those failing exercise screening protocol, as defined within the standard operating procedure developed by the NIHR Leicester Biomedical Research Centre (e.g., chest discomfort with exertion). Sub-study 2Additional criteria that outline inclusion for sub-study 2:
- •Male Sub-study 3Additional criteria that outline inclusion for sub-study 3:
- •Safe to undertake a brain scan using magnetic resonance imaging (MRI) – the study team will determine this.
- •Able to read instructions on a TV screen without prescription glasses (contact lenses may be allowed).
- •Regularly consume Western European or Mediterranean-style foods.
- •No strict dietary requirements or food allergies (e.g., vegetarian, vegan, lactose intolerant, nut allergy).
排除标准
- •Master Exclusion Criteria Individuals will be excluded if they meet any of the following:
- •Currently or previously (within the past 90 days before screening) participating in a weight loss intervention or group.
- •Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening.
- •Treatment with any medication for the specific purposes of weight loss within the past 90 days before screening.
- •Treatment with any GLP-1RA or DPP4 inhibitor therapies for glucose control or weight loss within the past 90 days before screening.
- •Hypersensitivity or allergy to GLP-1 agonists or their excipients.
- •Taking medication known to induce weight gain within the past 90 days before screening such as tricyclic antidepressants, atypical antipsychotics and mood stabilizers.
- •Other weight loss or gain therapy-specific contraindications as judged by the study clinician.
- •Glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations) within the past 90 days before screening, or have an active autoimmune abnormality that in the opinion of the trial clinician will require future treatment with systemic glucocorticoids.
- •Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L at screening (Visit 0).
- •Those failing exercise screening protocol, as defined within the standard operating procedure developed by the NIHR Leicester Biomedical Research Centre (e.g., chest discomfort with exertion).
- •Currently taking bolus insulin or using an insulin pump.
- •HbA1c = 10% at screening (Visit 0).
- •Blood pressure > 160/100 at screening (Visit 0).
- •Active or untreated malignancy or in remission for less than 3 years.
- •Current or planned pregnancy, or breastfeeding. Planned pregnancy in this instance involves women of childbearing potential (see definition in section 6.3) actively trying to become pregnant or aiming to become pregnant within the next six months.
- •Stage 3b CKD, defined as eGFR <30 ml/min/1.73m² at screening (Visit 0).
- •Any of the following: myocardial infarction, stroke, diagnosed heart failure or arrhythmogenic cardiomyopathy, atrial fibrillation, a pacemaker or implantable cardioverter defibrillator or hospitalisation for other cardiac events within the past six months.
- •Documented or self-reported liver cirrhosis.
- •Current participation in another research study with investigational medical products.
- •Serious illness with life expectancy < 1 year or other significant illness or disability which, in the opinion of the principal investigator or study clinician, precludes involvement.
- •Individuals with acute pancreatitis or a history of chronic pancreatitis.
- •Have a history of active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder) within the last 2 years. Patients with MDD or a generalized anxiety disorder whose disease state is considered stable may be considered for inclusion if they are not on excluded medications.
- •Personal or family h
结局指标
主要结局
Physical function measured using meters covered during the incremental shuttle walk test at baseline and week 24
次要结局
未报告次要终点
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