Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 6:19 PM
Study NCT ID:
NCT03207269
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2017-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2017-06-30', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Plasma glucose', 'timeFrame': 'Day 4', 'description': 'Fasting Plasma glucose'}], 'secondaryOutcomes': [{'measure': '24 h mean blood glucose', 'timeFrame': 'Average of three days during each intervention', 'description': 'continuous blood glucose monitoring'}, {'measure': 'postprandial glucose', 'timeFrame': 'Average of three days during each intervention', 'description': 'breakfast AUC'}, {'measure': 'Fasting insulin', 'timeFrame': 'Average of three days during each intervention', 'description': 'Fasting plasma insulin'}, {'measure': 'Fasting homeostasis model assessment of insulin resistance (HOMA-IR)', 'timeFrame': 'Day 4', 'description': 'Calculated by fasting plasma glucose and insulin'}, {'measure': 'Overnight blood glucose', 'timeFrame': 'Average of three days during each intervention', 'description': 'Glucose assessed during sleep by continuous glucose monitoring'}, {'measure': 'Fasting continuous glucose monitoring glucose', 'timeFrame': 'Average of the three days during each intervention', 'description': '15-minute average glucose assessed by CGM in the fasted state upon awakening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '32204977', 'type': 'DERIVED', 'citation': 'Abbie E, Francois ME, Chang CR, Barry JC, Little JP. A low-carbohydrate protein-rich bedtime snack to control fasting and nocturnal glucose in type 2 diabetes: A randomized trial. Clin Nutr. 2020 Dec;39(12):3601-3606. doi: 10.1016/j.clnu.2020.03.008. Epub 2020 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Approximately 3 million Canadians have type 2 diabetes, a condition where the blood sugar levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other complications. Patients with type 2 diabetes are often advised to consume a snack before bed in order to help control morning blood sugar levels. However, scientific evidence for this dietary approach is limited and there is no data to help elucidate what the ideal bedtime snack is. We hypothesize that a high protein, high fat snack with very little carbohydrate, will be an effective bedtime snack for lowering morning glucose without spiking glucose levels in the night. In this study we will determine if a bedtime snack that is high in protein and fat but low in carbohydrate can help improve morning glucose control in people with type 2 diabetes. This information will provide scientific evidence for the potential health benefits of strategically-timed high protein, high fat snack consumption in people with type 2 diabetes.', 'detailedDescription': 'Fifteen patients with physician diagnosed type 2 diabetes (HbA1c 6.5-9%), between the ages of 30-80 years, and not on exogenous insulin therapy, will complete three, 3-day intervention periods (proof-of-concept randomized trial). Participants will consume a standardized diet for three days with either i) two hard-boiled eggs, ii) fruit yogurt; or iii) control no-bedtime snack, thirty minutes prior to bedtime. Fasting blood samples will be obtained on Day 4 in the morning after following each 3-day dietary intervention. Blood glucose will be monitored continuously across the intervention period using continuous glucose monitoring (CGM). CGM allows for the moment-to-moment changes in blood glucose to be examined for several days, allowing the unique opportunity to examine the glucose responses at different points of the day, including fasting hyperglycemia in the morning, nocturnal glucose, and postprandial glucose in response to meals. To our knowledge, CGM technology has never been used in a bedtime snacking study in type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Type 2 Diabetes\n* HbA1c between 6.5 - 9.0%\n* No dietary restraints (lactose intolerance, dislike eggs, celiac disease)\n\nExclusion Criteria:\n\n* Heart attack or stroke within last year\n* Exogenous insulin'}, 'identificationModule': {'nctId': 'NCT03207269', 'briefTitle': 'Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'A High-protein Bedtime Snack to Control Morning Blood Glucose', 'orgStudyIdInfo': {'id': 'H17-01055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High protein no carbohydrate', 'description': 'Dietary. Two eggs will be consumed 30 minutes prior to bedtime. Energy content of dinner will be reduced to account for the calories in the bedtime snack.', 'interventionNames': ['Other: Dietary']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High protein carbohydrate containing', 'description': 'Dietary. A low-fat yogurt will be consumed 30 minutes prior to bedtime. Protein will be matched to the high protein bedtime snack condition. Energy content of dinner will be reduced to account for the calories in the bedtime snack.', 'interventionNames': ['Other: Dietary']}, {'type': 'NO_INTERVENTION', 'label': 'Control no snack', 'description': 'No snack will be consumed prior to bed.'}], 'interventions': [{'name': 'Dietary', 'type': 'OTHER', 'description': 'Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.', 'armGroupLabels': ['High protein carbohydrate containing', 'High protein no carbohydrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1V 1V7', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia, Okanagan.', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jonathan Little', 'investigatorAffiliation': 'University of British Columbia'}}}}