Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT04076995
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2019-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004326', 'term': 'Drinking'}], 'ancestors': [{'id': 'D004435', 'term': 'Eating'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2019-08-27', 'studyFirstSubmitQcDate': '2019-08-30', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve of Glucose at lunch', 'timeFrame': '2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)'}, {'measure': 'Area under the curve of Glucose at Dinner', 'timeFrame': '2-hour window starting right before dinner (4:00 pm - 6:00 pm)'}, {'measure': 'Area under the curve of Glucose for the entire experiment', 'timeFrame': '11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)'}, {'measure': 'Area under the curve of Copeptin for the entire experiment', 'timeFrame': '11-hour window starting right before breakfast till 2 hours after dinner (7:00 am - 6:00 pm)'}, {'measure': 'Area under the curve of Glucagon at lunch', 'timeFrame': '2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)'}, {'measure': 'Area under the curve of Glucagon at dinner', 'timeFrame': '2-hour window starting right before dinner (4:00 pm - 6:00 pm)'}, {'measure': 'Urinary glucose excretion', 'timeFrame': 'Entire 11-hour protocol 7:00 am - 6:00 pm'}, {'measure': 'Area Under the Curve for Plasma osmolality', 'timeFrame': 'the entire 11-hour protocol 7:00 am - 6:00 pm'}], 'secondaryOutcomes': [{'measure': 'Area under the curve of Insulin at lunch', 'timeFrame': '2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)'}, {'measure': 'Area under the curve of Insulin at dinner', 'timeFrame': '2-hour window starting right before dinner (4:00 pm - 6:00 pm)'}, {'measure': 'Area under the curve of Glucagon like peptide 1 at dinner', 'timeFrame': '2-hour window starting right before dinner (4:00 pm - 6:00 pm)'}, {'measure': 'Area under the curve of Glucagon like peptide 1at lunch', 'timeFrame': '2-hour window starting right before the lunch meal (12:00 pm - 2:00 pm)'}, {'measure': 'Area under the curve of plasma cortisol', 'timeFrame': 'the entire 11-hour protocol 7:00 am - 6:00 pm'}, {'measure': 'Area under the curve for Thirst rating', 'timeFrame': 'the entire 11-hour protocol 7:00 am - 6:00 pm', 'description': 'Thirst assessed by Visual analog scale'}, {'measure': 'Mood assessment with a questionnaire', 'timeFrame': 'single measurement at baseline before the beginning of breakfast at 7:00 am and 1-hour before dinner meal at 3:00 pm', 'description': 'Assessed by Profile of mood state questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dehydration', 'vasopressin', 'copeptin'], 'conditions': ['Dehydration', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Previous studies have indicated increased vasopressin due to hypertonic saline infusion impairs glucose regulation. The current study will examine the effect of low water intake on glucose regulation. No currently published study has investigated the acute effect of low water intake on glucose regulation using continuous glucose monitoring over the course of a full day. The aim of the study is to observe the effect of low water intake on glucose regulation in low drinkers. The study will study the glycemic responses to standardized meals in adults during an 11-hour period in two conditions: a) high water intake and b) low water intake. It is hypothesized that the area under the glucose curve will be greater in the low water intake trial as compared to the high water intake trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy sedentary participants\n* aged 30-55 years\n* body mass 27.5-35.0 kg·m2\n* low water intake less than 1.5 L∙day-1 (male) or 1.0 L∙day-1 (female)\n* 24 h urine osmolality greater than 800 mmol/kg\n\nExclusion Criteria:\n\n* diabetes HbA1c \\>6.5%\n* impaired liver or kidney function\n* cardiovascular disease\n* weight change of more than 3 kg in the past month\n* pregnancy\n* previous surgery on digestive tract\n* exercise \\>4 h/week'}, 'identificationModule': {'nctId': 'NCT04076995', 'acronym': 'INDIGO-2', 'briefTitle': 'INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'INDIGO-2: The Effect of High Water Intake on Glucose Regulation in Low-drinkers', 'orgStudyIdInfo': {'id': 'STUDY00010276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Water intake', 'description': 'High water intake of 3.0 L/day in males and 2.0 L/day in females', 'interventionNames': ['Other: Water Intake']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low Water Intake', 'description': 'Low water intake of 0.5 L/day in males and 0.4 L/day', 'interventionNames': ['Other: Water Intake']}], 'interventions': [{'name': 'Water Intake', 'type': 'OTHER', 'description': 'Increased water intake during the 11 h protocol', 'armGroupLabels': ['High Water intake', 'Low Water Intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Biomedical Collaborative', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}