Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-24 @ 4:46 PM
Study NCT ID:
NCT03347305
Status:
UNKNOWN
Last Update Posted:
2019-02-04
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of the Energy Metabolism of Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy expenditure measured by indirect calorimetry in a calorimetric chamber', 'timeFrame': 'at day 1', 'description': 'Energy expenditure measured by indirect calorimetry in a calorimetric chamber'}], 'secondaryOutcomes': [{'measure': 'respiratory quotient (RQ)', 'timeFrame': 'at day1', 'description': 'Nature of the oxidized nutrients determined from the measurement of the respiratory quotient'}, {'measure': 'Actimetry', 'timeFrame': 'at day 1', 'description': 'Estimated ambulatory energy expenditure from heart rate'}, {'measure': 'HGPO', 'timeFrame': 'at day 1', 'description': 'Charges of blood insulin concentration, and glucose in response to oral glucose load'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Energy expenditure', 'Peritoneal dialysis'], 'conditions': ['Renal Failure']}, 'descriptionModule': {'briefSummary': 'The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.\n\nThe main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.', 'detailedDescription': 'The daily energy expenditure of patients treated with peritoneal dialysis could be increased compared to the general population and promote the development of a state of undernutrition. Conversely, the absorption of glucose by transperitoneal route could contribute to the occurrence of a metabolic syndrome.\n\nThe main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients Group DPA\n\n * Male patients\n * Aged 18 to 70 years\n * With end-stage renal disease\n * Treated by automatic peritoneal\n * Social security cover\n * Without acute events in the 3 months prior to inclusion\n * PCR \\< 30 mg/L\n * Written informed consent\n * Baecke activity score from 5 to 10\n\nHealthy Volunteers\n\n* Male patients\n* Aged 18 to 70 years\n* Patients matched by lean body mass (± 2 kgs) and age (± 5 years)\n* Having a glomerular filtration rate estimated with the formula CKD-EPI creatinine \\> 60 mL / min / 1.73 m 2\n* PCR \\< 3 mg/L\n* Social security cover\n* Written informed consent\n* Baecke activity score from 5 to 10\n\nExclusion Criteria:\n\n* • - Female\n\n * Type 1 or 2 diabetes requiring a antidiabetic treatment\n * Decompensated heart failure\n * Smoking more than 5 cigarettes a day\n * Alcoholic patients, drinking more than 3 glass of alcohol a day\n * Patient Corticotherapy in progress\n * Patient with evolutive acute pathology\n * Person who has participated in another study within the last 30 days or is in period of exclusion on the National File of Healthy Volunteers'}, 'identificationModule': {'nctId': 'NCT03347305', 'acronym': 'CALIMERO 2', 'briefTitle': 'Measurement of the Energy Metabolism of Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Study in Calorimetric Room of the Energy Metabolism of Renal Impairment Patients Treated With Automated Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'CHU-364'}, 'secondaryIdInfos': [{'id': '2015-A00035-44', 'type': 'OTHER', 'domain': '2015-A00035-44'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients Group DPA', 'description': 'The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber', 'interventionNames': ['Behavioral: automated DP']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'description': 'The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber', 'interventionNames': ['Behavioral: Calorimetric chamber']}], 'interventions': [{'name': 'automated DP', 'type': 'BEHAVIORAL', 'description': 'Energy expenditure measurement', 'armGroupLabels': ['Patients Group DPA']}, {'name': 'Calorimetric chamber', 'type': 'BEHAVIORAL', 'description': 'The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber', 'armGroupLabels': ['Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '0473751195'}, {'name': 'Julien ANIORT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marc BOUILLER', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Myriam ISNARD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Didier AGUILERA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '0473751195'}], 'overallOfficials': [{'name': 'Julien ANIORT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pôle Santé République', 'class': 'OTHER'}, {'name': 'Service de Néphrologie et Hémodialyse', 'class': 'UNKNOWN'}, {'name': 'Jacques Lacarin Hospital Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}