Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05668520
Status:
UNKNOWN
Last Update Posted:
2022-12-29
First Post:
2022-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of Nutritional Status in Patients With Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'satisfactory completion of body composition', 'timeFrame': 'assessed at study visit for each participant', 'description': 'measurement of body composition using hand-held body fat monitor'}, {'measure': 'measurement of resting metabolic rate', 'timeFrame': 'assessed at study visit for each participant', 'description': 'measurement of Resting Metabolic Rate (RMR) using a ventilated hood system'}, {'measure': 'measurement of body weight', 'timeFrame': 'assessed at study visit for each participant', 'description': 'body weight in kg'}, {'measure': 'measurement of height', 'timeFrame': 'assessed at study visit for each participant', 'description': 'height in metres'}, {'measure': 'completion of measurement of waist, arm and calf circumference', 'timeFrame': 'assessed at study visit for each participant', 'description': 'measurement of waist circumference, mid upper arm and calf circumference using a tape measure'}, {'measure': 'nutritional assessment', 'timeFrame': 'assessed at study visit for each participant', 'description': 'estimation of energy, protein, carbohydrate and fat intake using MNA and MUST questionnaires'}], 'secondaryOutcomes': [{'measure': 'variability of measures to power future grant applications', 'timeFrame': 'at end of study', 'description': 'Descriptive statistics of each measurement by group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Huntington Disease']}, 'descriptionModule': {'briefSummary': 'It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. Our long term goal is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. We want to know which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status.', 'detailedDescription': "Huntington's disease (HD) is a complex autosomal dominant disorder of (generally) adult onset. The clinical features of HD are cognitive decline, psychiatric disturbance, personality change and movement disorder. Although by EU definition a rare disease, better management and establishment of clinics for care of HD around the world have led to recognition of that the condition is much more common than previously considered.\n\nGrampian has one of the longest established clinics for managing HD worldwide, and we now care for more than 150 people at different stages in HD, making us one of the largest five specialist clinics in the UK. Members of our team have led the production of European guidelines for HD management, and within this project, we have highlighted the importance of nutrition in HD. Weight loss is well documented as a clinical feature of all stages of Huntington's disease (HD). However, its metabolic basis is poorly understood and appetite has not been formally studied in patients with the condition. Furthermore, the composition of weight loss - muscle or fat has been little studied and modern nutrition assessment tools have not been applied in this cohort. It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. The long term goal of this study is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. The aim is to identify which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "manifesting Huntington disease patients of North of Scotland Huntington's clinic", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stage 2 or 3 Huntington disease\n\nExclusion Criteria:\n\n* unable to give consent'}, 'identificationModule': {'nctId': 'NCT05668520', 'briefTitle': "A Pilot Study of Nutritional Status in Patients With Huntington's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': "A Pilot Study of Nutritional Status in Patients With Huntington's Disease", 'orgStudyIdInfo': {'id': '2-095-19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'weight stable', 'description': 'stage 2 and 3 as defined by the UHDRS Total Functional Capacity score will be recruited. Ten will have reported at least 5% weight loss in a 12-month period,', 'interventionNames': ['Diagnostic Test: Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system']}, {'label': 'weight loss', 'description': 'stage 2 and 3 as defined by the UHDRS Total Functional Capacity score will be recruited. Ten will have reported at least 5% weight loss in a 12-month period,', 'interventionNames': ['Diagnostic Test: Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system']}], 'interventions': [{'name': 'Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Nutritional assessment'], 'description': 'Consent Paperwork\n\n* Nutritional assessment using MNA and MUST questionnaires\n* 24-hour dietary recall assessment Body weight, height, waist circumference, mid upper arm and calf circumference', 'armGroupLabels': ['weight loss', 'weight stable']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZA', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Zosia Miedzybrodzka', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'de-identified data sharing would be considered on request but would require additional permissions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zosia Miedzybrodzka', 'investigatorAffiliation': 'University of Aberdeen'}}}}