[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Manchester Metropolitan University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":141},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,81,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100634154","ibm-dietary-surveillance-study-100634154",false,"NCT07535996","IBM Dietary Surveillance Study","Surveying the Dietary Intake, Physical Activity Patterns, Muscle Strength and Morphology of Adults With Inclusion Body Myositis","Inclusion Criteria (Adults with IBM):\n\n* Diagnosis of Inclusion Body Myositis: As defined by the revised European Neuromuscular Centre 2013 diagnostic criteria (Definite or Probable IBM)\n* Age: Adults aged ≥40 years at the time of consent.\n* Ability to Provide Informed Consent: Participants must be cognitively capable of providing written, informed consent.\n* Disease Progression: Participants must be able to walk short distances, with or without the use of an assistive aid (e.g., a cane or frame) for balance, so that they can undertake study procedures without safety concerns. Must be able to consume solid or modified-texture food, with or without dysphagia adaptations (i.e., not exclusively tube-fed).\n* Willingness to Participate: Willing to attend study visits and comply with all study procedures.\n\nInclusion Criteria (Control Participants):\n\n* Disease-Free: Control participants must be generally healthy, with no known myopathies or metabolic diseases. They must not have any conditions that, in the judgement of a clinician, would compromise their safety, impair their ability to complete study procedures, or influence study outcomes.\n* Age: Adults aged ≥40 years at the time of consent.\n* Ability to Provide Written Informed Consent\n* Willingness to Participate\n* Matched to IBM participants according to their age and physical activity levels\n\nExclusion Criteria (Adults with IBM):\n\n* Coexisting Neuromuscular or Metabolic Disorders: Presence of other neuromuscular or metabolic disorders that may confound the outcomes of interest.\n* Severe Dysphagia: Participants requiring exclusive enteral or parenteral feeding, which would prevent participation in dietary intake assessments.\n* Enrolment in an interventional trial within the past 3 months: Participation in an interventional study within the past 3 months involving interventions that may affect dietary habits, physical activity, or muscle metabolism.\n* Contraindications to any Study Procedures: Any condition preventing safe completion of key assessments. For instance: severe osteoporosis contraindicating DXA scanning (T-score \\\u003C -3.0), respiratory conditions, severe claustrophobia, severe cognitive impairments or communication barriers that may impair participant ability to comply with study procedures.\n* Logistical Concerns: Any other logistical concern, as judged by the CI, that would compromise participant safety or the integrity of study data.\n* English Comprehension: Participants will be excluded if they are unable to understand written or verbal English to a degree that would impair their ability to provide informed consent or fully understand the study procedures.\n\nExclusion Criteria (Control Participants):\n\n* Diagnosed neuromuscular or metabolic Disorder\n* Enrolment in an interventional trial within the past 3 months\n* Contraindications to any study procedures such as those listed for IBM participants (e.g., DXA, MRI).\n* Logistical or safety concerns, as judged by the research team.\n* To minimise dietary overlap, individuals living in the same household as an IBM participant will not be eligible.\n* Do not meet the physical activity criteria to be appropriately matched to an IBM participant\n* Unable to understand written or verbal English",true,"ALL","40 Years",{"count":20,"type":21},47,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to understand how diet may influence the disease characteristics of inclusion body myositis (IBM). Research findings will help determine whether dietary factors could play a role in managing IBM.\n\nThe study aims to answer the question: Does diet affect the muscle health and functional ability of people living with IBM?\n\nResearchers will compare adults with IBM to healthy volunteers aged 40 years and older. This comparison will help to identify which findings are related to normal ageing and which are specific to IBM.\n\nParticipants will:\n\nAttend an initial screening visit at the Manchester Metropolitan University Institute of Sport to confirm eligibility and explain study procedures.\n\nComplete four weeks of home-based monitoring, including dietary records, physical activity monitoring, and questionnaires about lifestyle and symptoms.\n\nAttend a second university visit for assessments of body composition, metabolism, and muscle function.",[25],"Inclusion Body Myositis",[25,27,28,29,30,31,32,33,34],"IBM","Skeletal muscle","Aging","Muscle function","Muscle strength","Case-control study","Diet","Nutrition","NOT_YET_RECRUITING","2026-04-10",{"date":38,"type":39},"2026-04-17","ACTUAL",{"date":41,"type":21},"2026-04-30",{"date":43,"type":21},"2026-12-31",{"name":45,"class":46},"Manchester Metropolitan University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100629616","effects-of-dual-source-carbohydrate-intake-and-liver-glycogen-repletion-after-overnight-fasting-100629616","NCT07476989","Effects of Dual-Source Carbohydrate Intake and Liver Glycogen Repletion After Overnight Fasting.","The Effects of a Dual-Source High-Carbohydrate Breakfast on Hepatic Glycogen Storage Following an Overnight Fast.","Inclusion Criteria:\n\n* A male (at birth) aged between 18 and 45.\n* Regularly training for a specific sport (must include cycling) at least 3 times per week (with the purpose of competing).\n* VO2 peak \\>50 (ml.kg.min)\n* A current non-smoker\u002Fvaper (must not have smoked or vaped within the last 6 months)\n* Do not have any medical conditions or are taking any medications or supplements which can affect the study's outcome measures.\n* Free from any metallic implants, including permanent jewellery (that can't be removed)\n* No known intolerances or allergies to any component of the nutritional supplement\n\nExclusion Criteria:\n\n* Are not a male (at birth) aged between 18 and 45.\n* Do not regularly train for a specific sport (must include cycling) at least 3 times per week (with the purpose of competing).\n* Does not have a VO2 max\u002Fpeak \\>50 (ml.kg.min)\n* A current smoker\u002Fvaper (must not have smoked or vaped within the last 6 months)\n* Have any medical conditions or are taking any medications or supplements which can affect the study's outcome measures\n* Have any metallic implants, including permanent jewellery (that can't be removed)\n* Known intolerances or allergies to any component of the nutritional supplement.","MALE","18 Years","45 Years",{"count":59,"type":21},12,"INTERVENTIONAL",[62],"NA","This study is looking at whether eating a breakfast which has two different sources of carbohydrates, glucose and fructose (found in foods like honey and fruits), can increase how much glycogen can be stored in the liver. Glucose is a type of sugar that the body uses to provide energy during exercise. When it is not circulating in the blood, it is stored in the muscles and liver. The stored version of glucose is often referred to as glycogen. When the body needs energy, for example, it will break down glycogen into glucose so that it can be used as fuel.\n\nMuscle and liver glycogen stores are vital in providing energy during prolonged exercise, and strenuous activity can rapidly deplete these stores, leading to increased fatigue and a decline in performance. Liver glycogen, however, is particularly important because it controls blood glucose levels. This is important because the brain and other organs are constantly relying on the supply of glucose to function properly.\n\nWhen sleeping, the body goes through a natural period of fasting. During this period, the liver gradually breaks down its glycogen stores to release glucose into the bloodstream. Because of this, following sleep, liver glycogen stores are automatically low (which is why having breakfast is important). There is research to suggest that eating a high-carbohydrate breakfast can prevent further declines in liver glycogen; however, it is not known if eating different types of carbohydrates within the breakfast (glucose and fructose together) will affect the liver's ability to store glycogen. This research will aid in understanding optimal ways to increase liver glycogen stores before performing exercise, which may influence exercise performance.\n\nTherefore, the main aim of this study is:\n\n1\\. Investigate whether a high fructose breakfast will increase liver glycogen storage\n\nTo achieve this, participants will be recruited to complete a randomised crossover study where they will undertake three different conditions. All laboratory trials will take place at the Manchester Metropolitan University Institute of Sport.\n\n1. No breakfast (Control)\n2. 3 g\u002Fkg of body mass of carbohydrate (of which contains 0% fructose)\n3. 3 g\u002Fkg of body mass of carbohydrate (of which contains50% fructose)\n\nLiver glycogen stores will be measured using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). The investigators will measure liver glycogen content, liver volume, and stomach volume. Blood samples will also be taken to measure different metabolic hormone responses.",[65,66,67],"Carbohydrate Metabolism","Hepatic Glycogen Storage","Healthy Adult Male",[69,70,71,72],"Glucose","Fructose","Liver glycogen storage","Magnetic resonance spectroscopy","2026-03-12",{"date":75,"type":39},"2026-03-17",{"date":77,"type":21},"2026-03",{"date":79,"type":21},"2026-12",{"name":45,"class":46},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":60,"phases":90,"briefSummary":91,"conditions":92,"keywords":98,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":47},"100579699","heat-therapy-and-peripheral-artery-disease-100579699","NCT06827691","Heat Therapy and Peripheral Artery Disease","Heat Therapy for People with Peripheral Artery Disease: a Randomised Wait-List Controlled Feasibility Trial.","Inclusion Criteria:\n\n* • Aged \\> 18 years\n\n  * ABPI \\\u003C 0.9 at rest or a drop of 20mmHG after exercise testing\n  * Diagnosed with IC\n  * Able to walk unaided\n  * English-speaking and able to follow instructions\n  * No previous history of heat syncope\n  * Post-Menopausal or not on hormone therapy\n  * Able to provide informed consent\n\nExclusion Criteria:\n\n* • Walking impairment for a reason other than PAD\n\n  * Critical limb ischaemia\u002Frest pain\n  * Asymptomatic PAD\n  * Active cancer treatment\n  * Clinically diagnosed diabetes or those with peripheral neuropathy\n  * Recent \u002F frequent heat exposure (e.g., sauna or hot tubs).\n  * severe aortic stenosis, unstable angina, recent MI, stroke or TIA",{"count":89,"type":21},70,[62],"The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.",[93,94,95,96,97],"Peripheral Arterial Disease","Cardiovascular Health","Vascular Function","Intermittent Claudication","Peripheral Vascular Diseases",[99,100,101,102],"heat therapy","cardiovascular health","endothelial function","heat intervention","2025-02-10",{"date":105,"type":39},"2025-02-14",{"date":107,"type":21},"2025-05-01",{"date":109,"type":21},"2028-01-01",{"name":45,"class":46},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":60,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":47},"100572889","driving-with-neuropathy-100572889","NCT06739135","Driving with Neuropathy","Enabling People with Diabetic Neuropathy to Drive Safely: a Proof of Concept Randomised Controlled Trial","Inclusion Criteria:\n\n* Able to understand English and all of the study requirements, including ability to provide informed consent\n* Current full UK driving licence held, and for a minimum of 5 years (experienced drivers)\n* Drives a car at least once per week on average (current drivers)\n* Diagnosed with type 2 diabetes and diabetic peripheral neuropathy\n* Diagnosed with type 2 diabetes only (no diagnosed diabetic peripheral neuropathy)\n\nExclusion Criteria:\n\n* Active foot ulcer on either foot\n* Lower limb amputation involving more than two toes on the right foot\n* Dementia\n* Current participation in another research study that would compromise safety, or scientific integrity of either study (for example, a pharmaceutical trial that may affect ability to drive safely).","25 Years","69 Years",{"count":121,"type":21},115,[62],"This study is a proof-of-concept randomised controlled trial (RCT). The goal of the study is to investigate the effectiveness of a feedback intervention to improve use of the accelerator pedal in patients driving with diabetes and peripheral neuropathy (DPN).\n\nThe main (primary) question it aims to answer is:\n\nWhat is the effect of a visual feedback intervention (over 6 sessions a month apart), compared to no feedback, on accelerator pedal use by drivers with diabetic peripheral neuropathy?\n\nOur working hypothesis is that the visual feedback intervention will reduce the % of drive time with the accelerator pedal pushed down further than 9 degrees (about halfway down), the point at which the visual feedback (a warning signal) is triggered.\n\nSecondary research questions are:\n\n1. What is the effect of the feedback intervention on drivers with diabetic peripheral neuropathy at the first visit, and at the third visit? When does the biggest improvement happen? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time spent driving with the accelerator pedal pushed down further than 9 degrees, the point at which the feedback is triggered, in the first visit (ie with the first exposure to feedback) and by additional amounts in subsequent visits ie there will be an immediate benefit, and additional benefits that accrue gradually with repetition over the 6 monthly visits.\n2. What is the effect of the feedback intervention on a second variable, % of drive time with the vehicle 'out of control'. Out of control is defined as extreme use of the steering wheel, large and rapid movements that reach the full range of motion of the steering wheel or large swings back and forth together with excursion out of lane which the driver fails to prevent.\n\nOur working hypothesis is that the visual feedback intervention will reduce the % of drive time with the vehicle out of control.\n\nResearchers will compare the group of drivers with neuropathy who receive the intervention with a control group who do not.\n\nIn addition, a group of drivers who have diabetes but no diagnosed neuropathy will be studied. This is to seek confirmatory evidence (previously seen in a small sample in a previous study) that most drivers who have no diagnosed neuropathy do not push the accelerator pedal down more than 9 degrees and so do not need to improve their use of the accelerator pedal.\n\nParticipants will have their driving assessed in a driving simulator. Participants with DPN who push the accelerator pedal down more than 9 degrees will then be randomly allocated to the intervention group or control group. Only drivers in the intervention group will go on to experience the visual feedback intervention (in 6 sessions a month apart). Drivers in the control group will have their driving assessed at their first visit, and then at two later visits timed to coincide with the 3rd and 6th visit by drivers in the intervention group. This is the minimum necessary to be able to compare their driving with the intervention group at the start, midpoint and end of the intervention.",[125,126],"Diabetic Polyneuropathy","Diabetes Mellitus, Type 2",[128,129,130,131],"randomised controlled trial","diabetic peripheral neuropathy","driving","driving with neuropathy","RECRUITING","2024-12-16",{"date":135,"type":39},"2024-12-18",{"date":137,"type":39},"2024-10-25",{"date":139,"type":21},"2026-07",{"name":45,"class":46},""]