Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT01396460
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2011-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062408', 'term': 'Breakfast'}], 'ancestors': [{'id': 'D062407', 'term': 'Meals'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-07', 'studyFirstSubmitDate': '2011-07-15', 'studyFirstSubmitQcDate': '2011-07-15', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diet Induced Thermogenesis', 'timeFrame': '20min after standard meal', 'description': 'To examine the possible changes in the thermic effect of food, the patients received a standard meal. They then repeated the test 20 minutes after eating to obtain a reading of the metabolic rate by considering the DIT and RQ in the postprandial period. DIT was calculated as the difference between post prandial metabolic rate and RMR.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['respiratory quotient', 'fat oxidation', 'morbid obesity', 'bariatric', 'Bariatric Surgery'], 'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period.\n\nDiet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients.\n\nThe purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Bariatric post operative population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (bariatric patients post-op)\n\n* With more than 1 year after surgery\n* Consent given to participate\n\nExclusion Criteria:\n\n* Pregnant women\n* Malnourished patients (anemia)\n* Tiroid disorders without treatment'}, 'identificationModule': {'nctId': 'NCT01396460', 'acronym': 'RQ', 'briefTitle': 'Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gastrocirurgia, Brazil'}, 'officialTitle': 'Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients', 'orgStudyIdInfo': {'id': 'NCT01231087'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bariatric patients', 'description': 'Bariatric post operative patients were compared with morbid obese population', 'interventionNames': ['Other: breakfast (a chicken sandwich with juice)']}, {'label': 'control group', 'description': 'morbid obese population'}], 'interventions': [{'name': 'breakfast (a chicken sandwich with juice)', 'type': 'OTHER', 'description': 'patients received a breakfast after de initial measurement', 'armGroupLabels': ['bariatric patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70390108', 'city': 'BrasÃlia', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Gastrocirurgia de Brasilia', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gastrocirurgia, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Silvia Leite Faria , MSc, RD', 'investigatorFullName': 'Silvia Leite Faria', 'investigatorAffiliation': 'Gastrocirurgia, Brazil'}}}}