Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 2:55 AM
Study NCT ID:
NCT04923503
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2021-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'subject with random allocation Investigator do not know the group the analysator do not know the group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'three arm parallel group with 45 subjects:\n\n1. fasting in lean group\n2. fasting in obese group\n3. fasting in diabetics group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-26', 'studyFirstSubmitDate': '2021-06-06', 'studyFirstSubmitQcDate': '2021-06-06', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change acylated ghrelin', 'timeFrame': '30 days', 'description': 'Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen'}, {'measure': 'change PYY', 'timeFrame': '30 days', 'description': 'Change from Baseline PYY at 30 days taken in the lab from venous blood specimen'}, {'measure': 'change GLP-1', 'timeFrame': '30 days', 'description': 'Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen'}, {'measure': 'change insulin', 'timeFrame': '30 days', 'description': 'Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen'}], 'secondaryOutcomes': [{'measure': 'change body weight', 'timeFrame': '30 days', 'description': 'Change from Baseline body weight at 30 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gut hormones', 'metabolic parameters', 'obesity', 'lean', 'diabetics', 'ramadan fasting'], 'conditions': ['Fasting', 'Gut Hormone']}, 'descriptionModule': {'briefSummary': 'Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Because of its distinctive features, Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily physical activity, which may contribute to changes in hunger-satiety responses and glicemic control. Examining changes in gut hormones during Ramadan fasting may reveal whether this observance could change glucose metabolism in diabetics without triggering the undesirable effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary between outside and within Ramadan. Alterations in timing and composition meal during Ramadan lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this study to determine whether the effect of Ramadan fasting differed in people with DM patients, pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic parameters, and glycemic control', 'detailedDescription': 'The experimental study was performed during and after Ramadan fasting in 2021 (April to May) in Semarang, Indonesia. The present study was performed using the quasy-experimental method by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects) selected using the purposive sampling methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetics subjects: glucose fasting plasma \\> 200 mg/dL, with aged 35-60 years and body mass index above 25 kg/m;\n* Obese subjects: body mass index above 25 kg/m2 with aged 35-60 years and waist circumference for men \\>90 cm, for women \\> 80 cm\n* Lean subjects: body mass index below 23.5 kg/m2 with aged 35-60 years and waist circumference for men \\<90 cm, for women \\< 80 cm\n\nExclusion Criteria:\n\n* experienced weight loss more than 10% from the actual weight in the last three months\n* consumed medicine or supplement for weight loss diet, •. had the history of evidence of clinical depression, cognitive disorders, heart disease, cancer, liver or renal disease, chronic pulmonary disease, uncontrolled hypertension, physical disability, or other contraindications'}, 'identificationModule': {'nctId': 'NCT04923503', 'briefTitle': 'Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Diponegoro'}, 'officialTitle': 'Department of Nutrition Science, Medical Faculty, Universitas Diponegoro, Semarang, Indonesia', 'orgStudyIdInfo': {'id': 'RMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lean ramadan fasting', 'description': 'conduct ramadan fasting for 30 days', 'interventionNames': ['Behavioral: diurnal fasting']}, {'type': 'EXPERIMENTAL', 'label': 'obese ramadan fasting', 'description': 'conduct ramadan fasting for 30 days', 'interventionNames': ['Behavioral: diurnal fasting']}, {'type': 'EXPERIMENTAL', 'label': 'diabetics ramadan fasting', 'description': 'conduct ramadan fasting for 30 days', 'interventionNames': ['Behavioral: diurnal fasting']}], 'interventions': [{'name': 'diurnal fasting', 'type': 'BEHAVIORAL', 'otherNames': ['ramadan fasting'], 'description': 'subject conduct fasting in Ramadan for 30 days', 'armGroupLabels': ['diabetics ramadan fasting', 'lean ramadan fasting', 'obese ramadan fasting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50275', 'city': 'Semarang', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'Etika Ratna Noer', 'geoPoint': {'lat': -6.99306, 'lon': 110.42083}}], 'overallOfficials': [{'name': 'Etika R Noer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diponegoro University'}]}, 'ipdSharingStatementModule': {'url': 'http://dept-gizi@fk.undip.ac.id', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'anytime', 'ipdSharing': 'YES', 'description': 'the result of this study is available to cite everyone', 'accessCriteria': 'etikaratna@fk.undip.ac.id'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Diponegoro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Nutrition, Medical Faculty', 'investigatorFullName': 'Etika Ratna Noer', 'investigatorAffiliation': 'Universitas Diponegoro'}}}}