Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-03 @ 7:08 AM
Study NCT ID:
NCT02667769
Status:
UNKNOWN
Last Update Posted:
2016-08-16
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Protocols on the Implementation of a Fasting Day in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2016-01-26', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma glucose day- and night profiles', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fasting']}, 'referencesModule': {'references': [{'pmid': '28058800', 'type': 'DERIVED', 'citation': 'Haase M, Kahle M, Janert M, Meier JJ, Nauck MA. Basal rate tests (24-hour fasts) performed in type-1 diabetic subjects with either absolute fasting or snacks containing negligible carbohydrate amounts result in similar glucose profiles: A randomized controlled prospective trial. Diabetes Obes Metab. 2017 Jun;19(6):783-790. doi: 10.1111/dom.12868. Epub 2017 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective study with a "crossover design", where fasting with a day of complete fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods are compared in a randomized order. Underlying hypothesis is that at the same basal insulin substitution with the fasting of both protocols , no significant differences in the glucose-day or -night profiles revealed. So the same conclusions regarding the "consistency" of basal insulin dosing revealed during the implementation of the part of patients is rated as more pleasant when calories and carbohydrates-free food are allowed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes\n* Basal insulin substitution with neutrales Protamin Hagedorn (NPH) -insulin (at least twice a day), insulin detemir (twice a day), insulin glargine (once or twice a day) or with insulin pump\n* Diabetes duration \\> 2 years\n* Body-mass-index between 19 and 35 kg/m², including\n* written consent\n\nExclusion Criteria:\n\n* No pregnancy in woman'}, 'identificationModule': {'nctId': 'NCT02667769', 'briefTitle': 'Comparison of Two Protocols on the Implementation of a Fasting Day in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Diabeteszentrum Bad Lauterberg im Harz'}, 'officialTitle': 'Comparison of Two Protocols on the Implementation of a Fasting Day to Check the Basal Insulin Replacement in Type 1 Diabetes: Complete Fasting Compared to the Permission for Carbohydrate- and Calorie-free Food', 'orgStudyIdInfo': {'id': 'DZBL-2014-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fasting day without any food', 'description': 'Complete fasting: On a fast day under this Protocol no solid food may be eaten unless it is solid, medically prescribed part of a bedtime snack just before falling asleep (which must sometimes be to prevent nocturnal hypoglycaemia with injection of basal insulin before going to sleep) , Otherwise, the patient have ad libitum access to mineral water and unsweetened tea (possibly a fluid intake restriction should be considered for other diseases).', 'interventionNames': ['Other: Fasting day']}, {'type': 'OTHER', 'label': 'Fasting day with calorie- & carbohydrate-free food', 'description': 'During a fasting day for this protocol, patients may calories in unlimited quantity and (with calorie-free dressing) Take carb food like tomatoes, cucumbers, lettuce to be, both during meal periods and in between, if desired.', 'interventionNames': ['Other: Fasting day']}], 'interventions': [{'name': 'Fasting day', 'type': 'OTHER', 'description': 'A day of fasting started at 18.00 clock with a blood glucose test and is only started when on the same day no significant hypoglycemia (blood glucose \\<55 mg / dl) occurred, and when at 18.00 clock the blood sugar in the defined target range (70-180 mg / dl) is. Carried out during the fasting day standardized blood samples for measurement of plasma glucose with an appropriate laboratory method at 18.00, 20:00, 22:00, 12:00, 2:00, 4:00, 6:45, 9:00, 12:00, 14:00 and again at 18.00 clock. Because the determination of plasma glucose in the laboratory will take some time, is always for guidance and also measured with a fast measurement method, in order to treat at high levels of blood sugar with additional insulin correction, and to treat hypoglycaemia low blood sugar or to prevent hypoglycaemia.', 'armGroupLabels': ['Fasting day with calorie- & carbohydrate-free food', 'Fasting day without any food']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37431', 'city': 'Bad Lauterberg im Harz', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Diabeteszentrum Bad Lauterberg', 'geoPoint': {'lat': 51.63272, 'lon': 10.47031}}], 'overallOfficials': [{'name': 'Michael A. Nauck, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabeteszentrum Bad Lauterberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diabeteszentrum Bad Lauterberg im Harz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Michael A. Nauck', 'investigatorFullName': 'Michael A. Nauck', 'investigatorAffiliation': 'Diabeteszentrum Bad Lauterberg im Harz'}}}}