Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02990533
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2016-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'C004648', 'term': 'testosterone enanthate'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2020-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-13', 'studyFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Performance', 'timeFrame': 'Change from Baseline to 30-day Followup', 'description': 'Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance'}], 'secondaryOutcomes': [{'measure': 'Handgrip Strength', 'timeFrame': 'Change from Baseline to 30-day Followup', 'description': 'strength by handheld dynamometer, kg'}, {'measure': 'Physical Activity Level', 'timeFrame': 'Change from Baseline to 30-day Followup', 'description': 'Number of daily steps'}, {'measure': '30 day re-admission', 'timeFrame': '30 days post-discharge', 'description': 'Readmission within 30 days of hospital discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '41316872', 'type': 'DERIVED', 'citation': 'Arentson-Lantz EJ, Boyle JT, Deer RR, Kokonda M, Bennetsen D, Carreon SA, Meers JM, Taffet G, Vahidy FS, Agarwal KS, Volpi E, Nowakowski S. Association of Sleep Disturbance and Physical Functioning Following Acute Hospitalisation in Older Adults. J Sleep Res. 2025 Nov 29:e70252. doi: 10.1111/jsr.70252. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.', 'detailedDescription': 'The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the UTMB hospital\n* Aged 65 years or older\n* Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization\n* Alert and oriented x3 by a physician on H\\&P.\n* Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.\n\nExclusion Criteria:\n\n* A Nursing home resident or hospice care patient\n* Uncontrolled blood pressure (systolic \\>170, or diastolic \\> 100)\n* New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)\n* End stage renal disease\n* AST/ALT 2.5 times above the normal limit\n* Recent (within 3 months) or current treatment with anabolic steroids.\n* History of breast or prostate cancer\n* Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml (PSA ≥ 3 ng/ml in men at high risk of prostate cancer)\n* Hematocrit ≥ 50%\n* Any other condition or event considered exclusionary by the PI and faculty physician'}, 'identificationModule': {'nctId': 'NCT02990533', 'acronym': 'GRAMS', 'briefTitle': 'Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients', 'orgStudyIdInfo': {'id': '16-0146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Supplement Placebo Injection', 'interventionNames': ['Other: Placebo Injection', 'Other: Placebo supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone', 'description': 'Placebo Supplement Testosterone Injection', 'interventionNames': ['Drug: Testosterone', 'Other: Placebo supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Protein Supplement', 'description': 'Protein Supplement Placebo Injection', 'interventionNames': ['Dietary Supplement: Protein Supplement', 'Other: Placebo Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Protein Supplement + Testosterone', 'description': 'Protein Supplement Testosterone Injection', 'interventionNames': ['Drug: Testosterone', 'Dietary Supplement: Protein Supplement']}], 'interventions': [{'name': 'Testosterone', 'type': 'DRUG', 'otherNames': ['testosterone enanthate'], 'armGroupLabels': ['Protein Supplement + Testosterone', 'Testosterone']}, {'name': 'Protein Supplement', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['whey protein'], 'armGroupLabels': ['Protein Supplement', 'Protein Supplement + Testosterone']}, {'name': 'Placebo Injection', 'type': 'OTHER', 'otherNames': ['saline'], 'armGroupLabels': ['Placebo', 'Protein Supplement']}, {'name': 'Placebo supplement', 'type': 'OTHER', 'otherNames': ['maltodextrin'], 'armGroupLabels': ['Placebo', 'Testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Jennie Sealy Hospital', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Elena Volpi, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UTMB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}