Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-02-17 @ 11:06 PM
Study NCT ID:
NCT02683135
Status:
COMPLETED
Last Update Posted:
2017-08-03
First Post:
2016-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Control of Postprandial Hyperglycemia
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': 'D000076107', 'term': 'Diet, High-Protein Low-Carbohydrate'}, {'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}, {'id': 'D004032', 'term': 'Diet'}, {'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': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-01', 'studyFirstSubmitDate': '2016-02-11', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in flow-mediated dilation after single breakfast meal on day 1 of the intervention', 'timeFrame': 'Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm'}, {'measure': 'Change from baseline in plasma glucose after single breakfast meal on day 1 of the intervention', 'timeFrame': 'Baseline and 1, 2, and 3 hours post-breakfast on day 1 in each arm'}, {'measure': 'Change from baseline in body weight after a single meal and 4 days of intervention.', 'timeFrame': 'Fasting measures on day 1 and day 5.'}], 'primaryOutcomes': [{'measure': 'Difference in glycemic control assessed by continuous glucose monitoring in low-carbohydrate, low-carbohydrate plus post-meal walking, and high-carbohydrate low-fat arm.', 'timeFrame': '4-day average glucose levels assessed in each arm.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in circulating inflammatory cytokines after 4 days of intervention.', 'timeFrame': 'Fasting measurements taken on day 1 and day 5.'}, {'measure': 'Change from baseline in toll-like receptors 2 and 4 expression on white blood cells after 4 days of intervention.', 'timeFrame': 'Fasting measurements taken on day 1 and day 5.'}, {'measure': 'Change from baseline in flow mediated dilation of brachial artery after 4 days of intervention.', 'timeFrame': 'Fasting measurements taken on day 1 and day 5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Large spikes in blood glucose experienced after meals in people with type 2 diabetes are known to damage blood vessels. Low carbohydrate high fat diets and exercise can improve blood glucose control in people with type 2 diabetes but it is unclear how these two strategies interact to affect blood vessel function and inflammation. We will examine how following a short-term low carbohydrate high fat diet (4 days) with or without post-meal walking impacts markers of blood vessel function and inflammation. We will also examine how a single low carbohydrate high fat meal, with or without post-meal walking, impacts blood glucose control and blood vessel function. Findings will help determine the best lifestyle approach for improving cardiovascular health in type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes (at least 6 months ago)\n* Aged 40-75\n* Engaging in 2 or less moderate-to-vigorous exercise bouts per week in the last 3 months\n* Ability to understand and communicate in English to interact with the personal trainer\n\nExclusion Criteria:\n\n* Diagnosed coronary artery disease\n* Any contraindications to exercise (e.g., musculoskeletal injury)\n* Prior history of cardio- or cerebrovascular disease or myocardial infarction\n* Hypertension that is not controlled by medication (systolic blood pressure (BP) \\>160 mmHg and/or diastolic BP \\>99 mmHg)\n* Change in diabetes medications in the previous 6 months\n* Diagnosed with peripheral neuropathy\n* Taking exogenous insulin'}, 'identificationModule': {'nctId': 'NCT02683135', 'briefTitle': 'Lifestyle Control of Postprandial Hyperglycemia', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Low-carbohydrate Diet, With or Without Exercise, for Improving Postprandial Glucose Control and Vascular Function in Type 2 Diabetes and Prediabetes.', 'orgStudyIdInfo': {'id': 'H1501952'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-carbohydrate diet', 'interventionNames': ['Behavioral: High-carbohydrate diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low-carbohydrate diet', 'interventionNames': ['Behavioral: Low-carbohydrate diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low-carbohydrate diet with post-meal walking', 'interventionNames': ['Behavioral: Low-carbohydrate diet', 'Behavioral: Low-carbohydrate diet with post-meal walking']}], 'interventions': [{'name': 'High-carbohydrate diet', 'type': 'BEHAVIORAL', 'description': 'Participants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association. The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.', 'armGroupLabels': ['High-carbohydrate diet']}, {'name': 'Low-carbohydrate diet', 'type': 'BEHAVIORAL', 'description': 'Participants will engage in 4 days of low-carbohydrate high-fat diet. The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.', 'armGroupLabels': ['Low-carbohydrate diet', 'Low-carbohydrate diet with post-meal walking']}, {'name': 'Low-carbohydrate diet with post-meal walking', 'type': 'BEHAVIORAL', 'description': 'Participants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning \\~15 minutes after breakfast, lunch and dinner. Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.', 'armGroupLabels': ['Low-carbohydrate diet with post-meal walking']}]}, '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}}], 'overallOfficials': [{'name': 'Jonathan P Little, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jonathan Little', 'investigatorAffiliation': 'University of British Columbia'}}}}