Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-17 @ 4:44 PM
Study NCT ID:
NCT03233568
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2017-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Indirect Calorimetry in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weight in adequate to predicted REE and in NOT adequate to predicted REE subpopulations', 'timeFrame': '18 months', 'description': 'to compare body weight variation (kg) in two sub-populations of the IC-group: subjects with adequate to predicted REE and subjects with not adequate to predicted REE'}, {'measure': 'BMI in adequate to predicted REE and in NOT adequate to predicted REE subpopulations', 'timeFrame': '18 months', 'description': 'to compare BMI variation in two sub-populations of the IC-group: subjects with adequate to predicted REE and subjects with not adequate to predicted REE'}, {'measure': 'Weight in subjects with RQ<0.9 and subjects with RQ>0.9', 'timeFrame': '18 months', 'description': 'to compare body weight variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ \\> 0.9.'}, {'measure': 'BMI in subjects with RQ<0.9 and subjects with RQ>0.9', 'timeFrame': '18 months', 'description': 'BMI variation in 2 subpopulation of the IC group: subjects with an RQ ≤ 0.9 and subjects with RQ \\> 0.9.'}, {'measure': 'Glucose in Indirect Calorimetry group and in NO Indirect Calorimetry Group', 'timeFrame': '18 months', 'description': 'to identify differences in glucose (mg/dl) variation between IC and NO-IC groups'}, {'measure': 'Tryglycerides in Indirect Calorimetry group and in NO Indirect Calorimetry Group', 'timeFrame': '18 months', 'description': 'to identify differences in tryglycerides (mg/dl) variation between IC and NO-IC groups'}, {'measure': 'Total cholesterol (mg/dl) in Indirect Calorimetry group and in NO Indirect Calorimetry Group', 'timeFrame': '18 months', 'description': 'to identify differences in cholesterol variation between IC and NO-IC groups'}, {'measure': 'Hemoglobin in Indirect Calorimetry group and in NO Indirect Calorimetry Group', 'timeFrame': '18 months', 'description': 'to identify differences in glycated hemoglobin (%) variation between IC and NO-IC groups'}, {'measure': 'Uric acid in Indirect Calorimetry group and in NO Indirect Calorimetry Group', 'timeFrame': '18 months', 'description': 'to identify differences in uric acid (mg/dl) variation between IC and NO-IC groups'}], 'primaryOutcomes': [{'measure': 'Weight in Indirect Calorimetry group and in NO Indirect Calorimetry group', 'timeFrame': '18 months', 'description': 'To compare body weight variation (kg) in two groups of overweight or obese patients: subjects who followed a diet formulated on REE measured by IC (IC group) and subjects who followed a diet based on REE predicted by the Harris-Benedict formula (NO-IC group)'}, {'measure': 'BMI in Indirect Calorimetry group and in NO Indirect Calorimetry', 'timeFrame': '18 months', 'description': 'To compare BMI variation (kg/m\\^2) in two groups of overweight or obese patients: subjects who followed a diet formulated on REE measured by IC (IC group) and subjects who followed a diet based on REE predicted by the Harris-Benedict formula (NO-IC group)'}], 'secondaryOutcomes': [{'measure': 'Weight in male/female in Indirect Calorimetry group and in NO indirect Calorimetry group', 'timeFrame': '18 months', 'description': 'To identify gender differences in weight variation (kg) between IC and NO-IC groups'}, {'measure': 'BMI in male/female in Indirect Calorimetry group and in NO indirect', 'timeFrame': '18 months', 'description': 'To identify gender differences in BMI variation (kg/m\\^2) between IC and NO-IC groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolism Disorder', 'Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '29101542', 'type': 'DERIVED', 'citation': 'Massarini S, Ferrulli A, Ambrogi F, Macri C, Terruzzi I, Benedini S, Luzi L. Routine resting energy expenditure measurement increases effectiveness of dietary intervention in obesity. Acta Diabetol. 2018 Jan;55(1):75-85. doi: 10.1007/s00592-017-1064-0. Epub 2017 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will retrospectively analyze and compare data of 2 groups of overweight and obese patients: subjects who followed a diet based on Resting Energy Expenditure (REE) measured by indirect calorimetry and subjects who followed a diet based on REE estimated by the Harris-Benedict equation. Propensity score adjustment will be used to adjust for known differences between the 2 groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'To collect clinical data of a total population comprising patients referred to our Endocrinology-Diabetes Outpatient Clinic, in the period from April 2012 through October 2016.\n\nIn this retrospective study, will be considered patients with an age ranging from 20 to 86 years, with overweight (25 ≤ BMI ≤ 29.9) or obesity (BMI ≥ 30), requiring dietary intervention for weight control.\n\nStatistical analysis will perform on overweight and obese patients divided into two subgroups: IC group and NO-IC group.\n\nAnthropometric status and metabolic biomarkers will re-evaluated at check-ups performed after 3 months, 6 months, 12 months and 18 months from the baseline.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>25\n* Age ranging from 20 to 86 years\n\nExclusion Criteria:\n\n* BMI\\<25\n* Age \\<20\n* Age \\>86'}, 'identificationModule': {'nctId': 'NCT03233568', 'briefTitle': 'Use of Indirect Calorimetry in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Donato'}, 'officialTitle': 'Use of Indirect Calorimetry in Dietary Setting in Obese Subjects: Retrospective Observational Study', 'orgStudyIdInfo': {'id': 'CALO/Obesity'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Indirect Calorimetry group (IC group)', 'description': 'Group who performed indirect calorimetry. REE measured by indirect calorimetry.', 'interventionNames': ['Diagnostic Test: Indirect calorimetry']}, {'label': 'NO Indirect Calorimetry group (NO-IC group)', 'description': 'Group who did not perform indirect calorimetry. Resting Energy Expenditure calculated by Harris-Benedict formula'}], 'interventions': [{'name': 'Indirect calorimetry', 'type': 'DIAGNOSTIC_TEST', 'description': "Indirect calorimetry will be performed by using an open-circuit calorimeter (Sensor Medics, Italy). Indirect calorimetry is the reference method for energy expenditure determination. A canopy hood covered the patient's head and expired air is extracted by a pump to be analyzed by metabolic cart sensors; flow rate is directly measured with a digital turbine flowmeter. After an overnight fast, patients will asked to lay supine in complete physical rest, not sleeping or talking for approximately 20-25 minutes, at a room temperature ranged between 22 and 24°C. The mean REE for each participant considers the last 15-20 minutes of measurements corresponding to steady state.\n\nSoftware of calorimeter will be set for minute-by-minute reading report of VO2 (Oxygen flow) and VCO2 (Carbon dioxide flow) measurement.\n\nParameters obtained by Indirect Calorimetry will be the Resting Energy Expenditure and the Respiratory Quotient (RQ)", 'armGroupLabels': ['Indirect Calorimetry group (IC group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'MI', 'country': 'Italy', 'facility': 'San Donato Hospital', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}], 'overallOfficials': [{'name': 'Livio Luzi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Policlinico S. Donato'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Donato', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sub-Investigator', 'investigatorFullName': 'Anna Ferrulli', 'investigatorAffiliation': 'Ospedale San Donato'}}}}