Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-25 @ 12:05 PM
Study NCT ID:
NCT03054935
Status:
UNKNOWN
Last Update Posted:
2017-05-09
First Post:
2017-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002153', 'term': 'Calorimetry, Indirect'}], 'ancestors': [{'id': 'D002151', 'term': 'Calorimetry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Resting Energy Expenditure (REE) measured by Indirect Calorimetry (IC) in patients with Crohn's Disease", 'timeFrame': 'At baseline', 'description': 'The measurement of REE by IC is a non-invasive method that measures oxygen consumption and carbon dioxide production and it is generally considered the gold standard in clinical practice.'}], 'secondaryOutcomes': [{'measure': 'Body composition assessment by bioelectrical impedence analysis (BIA)', 'timeFrame': 'At baseline'}, {'measure': 'Assessment of muscle function by hand-grip strength', 'timeFrame': 'At baseline', 'description': 'Hand-grip strength will be performed by dynamometer'}, {'measure': 'Food intake evaluation', 'timeFrame': 'At baseline', 'description': 'Food intake will be assessed by filling 3 day food records'}, {'measure': 'Inflammatory biomarkers', 'timeFrame': 'At baseline', 'description': 'Serum concentration of high sensitive C-reactive protein (hs-RCP) will be determined by immunoturbidimetric assay while tumor necrosis factor - alpha (TNF-alpha) and Interleukin 6 (IL-6) will be assessed by ELISA.'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': 'At baseline', 'description': "Assessment of each patient's health and well-being using the short-form 36 (SF-36)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Energy Expenditure', 'Body Composition', 'Food Intake'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '10705071', 'type': 'BACKGROUND', 'citation': "Al-Jaouni R, Hebuterne X, Pouget I, Rampal P. Energy metabolism and substrate oxidation in patients with Crohn's disease. Nutrition. 2000 Mar;16(3):173-8. doi: 10.1016/s0899-9007(99)00281-6."}, {'pmid': '24668997', 'type': 'BACKGROUND', 'citation': "Gong J, Zuo L, Guo Z, Zhang L, Li Y, Gu L, Zhao J, Cao L, Zhu W, Li N, Li J. Impact of Disease Activity on Resting Energy Expenditure and Body Composition in Adult Crohn's Disease: A Prospective Longitudinal Assessment. JPEN J Parenter Enteral Nutr. 2015 Aug;39(6):713-8. doi: 10.1177/0148607114528360. Epub 2014 Mar 25."}, {'pmid': '1984342', 'type': 'BACKGROUND', 'citation': 'Kushner RF, Schoeller DA. Resting and total energy expenditure in patients with inflammatory bowel disease. Am J Clin Nutr. 1991 Jan;53(1):161-5. doi: 10.1093/ajcn/53.1.161.'}, {'pmid': '8125226', 'type': 'BACKGROUND', 'citation': 'Rigaud D, Cerf M, Angel Alberto L, Sobhani I, Carduner MJ, Mignon M. [Increase of resting energy expenditure during flare-ups in Crohn disease]. Gastroenterol Clin Biol. 1993;17(12):932-7. French.'}, {'pmid': '10203559', 'type': 'BACKGROUND', 'citation': "Schneeweiss B, Lochs H, Zauner C, Fischer M, Wyatt J, Maier-Dobersberger T, Schneider B. Energy and substrate metabolism in patients with active Crohn's disease. J Nutr. 1999 Apr;129(4):844-8. doi: 10.1093/jn/129.4.844."}, {'pmid': '16928471', 'type': 'BACKGROUND', 'citation': "Vaisman N, Dotan I, Halack A, Niv E. Malabsorption is a major contributor to underweight in Crohn's disease patients in remission. Nutrition. 2006 Sep;22(9):855-9. doi: 10.1016/j.nut.2006.05.013."}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate the effect disease activity on resting energy expenditure (REE), body composition, inflammatory markers, food intake and quality of life in subjects affected by Crohn's Disease (CD)", 'detailedDescription': "Malnutrition is a common sequel among patients affected by Crohn's disease (CD). The pathogenic mechanisms include poor dietary intake, increased resting energy expenditure (REE), nutrient malabsorption and loss. So far, few studies have been carried out in CD adult patients, assessing the effect of disease activity on both REE and body composition. Vaisman et al (2006) studied sixteen CD patients in remission (\\> 3 mo) and showed no effect of REE on lower BMI, although in the presence of similar energy intake in according with previous studies (Al-Jaouni et al., 2000; Schneeweiss et al., 1999). While, Gong et al., 2015 found that patients with active disease had an increase in REE compared to patients in remission as already shown by Rigaud et al., 1993; Kushner and Schoeller, 1991. Overall, the effect of disease activity on REE is still uncertain and requires further investigation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending Gastroenterology Unit', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Crohn's Disease\n\nExclusion Criteria:\n\n* Comorbidity affecting energy metabolism (diabetes mellitus, thyroid dysfunction, etc.)\n* History of acute or chronic liver or kidney disease\n* Current parenteral nutrition\n* Presence of fistulae, ileostomy or colostomy\n* Presence of extensive small bowel resection (residual small bowel \\< 2 meters)\n* Pregnancy or lactation"}, 'identificationModule': {'nctId': 'NCT03054935', 'acronym': 'REECD', 'briefTitle': "Resting Energy Expenditure Evaluation in Subjects With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': "The Effects of Disease Activity on Resting Energy Expenditure in Subjects With Crohn's Disease: A Cross-sectional Study", 'orgStudyIdInfo': {'id': '102/16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subject-CD', 'description': "Subjects with Crohn's Disease in active or quiescent phase, classified according to Crohn's Disease Activity Index (CDAI \\>150 active; CDAI \\< 150 quiescent)", 'interventionNames': ['Other: Indirect Calorimetry']}], 'interventions': [{'name': 'Indirect Calorimetry', 'type': 'OTHER', 'description': 'Measurement of resting energy expenditure', 'armGroupLabels': ['Subject-CD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabrizio Pasanisi, MD, PhD', 'role': 'CONTACT', 'email': 'pasanisi@unina.it', 'phone': '+39 0817464747'}, {'name': 'Iolanda Cioffi, PhD', 'role': 'CONTACT', 'email': 'iolanda.cioffi@unina.it', 'phone': '+39 081 7462333'}, {'name': 'Fabiana Castiglione, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Federico II University Hospital', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Fabrizio Pasanisi, MD, PhD', 'role': 'CONTACT', 'email': 'pasanisi@unina.it', 'phone': '+39 081 7464747'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fabrizio Pasanisi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fabiana Castiglione', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Fabrizio Pasanisi', 'investigatorAffiliation': 'Federico II University'}}}}