Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2026-01-25 @ 7:18 AM
Study NCT ID:
NCT02804932
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nitrate Supplementation and Exercise Tolerance in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'darren-casey@uiowa.edu', 'phone': '13193841009', 'title': 'Dr. Darren Casey', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Final number of participants studied with muscle biopsies was smaller than the total number of subjects enrolled in the study. The lower number was influenced by: (i) subjects not consenting to the muscle biopsy procedure; or (ii) technical problems occurring in at least one of the testing visits (ex: not enough muscle tissue and/or extensive proportion of intramuscular fat obtained).'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the duration each subject was enrolled in the study, which was up to 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Beetroot Crystals (Nitrate)', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.\n\nSuper Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (Beetroot Powder, no Nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.\n\nSuper Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nondiabetic Control Subjects', 'description': "All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation.", 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximal Exercise Capacity (VO2max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Beetroot Crystals (Nitrate)', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.\n\nSuper Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo (Beetroot Powder, no Nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.\n\nSuper Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks'}, {'id': 'OG002', 'title': 'Nondiabetic Control Subjects', 'description': "All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation."}], 'classes': [{'title': 'VO2max - Pre supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.7', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '27.6', 'spread': '8.7', 'groupId': 'OG002'}]}]}, {'title': 'VO2max - Post supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.9', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre and post 8 weeks of dietary nitrate supplementation', 'description': 'A 12-lead ECG, symptom limited cardiopulmonary exercise testing with gas exchange measurements will be performed on a cycle ergometer using a ramp protocol to determine maximal aerobic capacity (VO2max) and exercise efficiency.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in the nitrate group did not reach maximal criteria during testing. Therefore, VO2max data was analyzed only in 18 participants in the nitrate group. Nondiabetic control subjects only completed VO2max testing once (same time point as pre measurements for T2D subjects).'}, {'type': 'PRIMARY', 'title': 'Change in Skeletal Muscle Perfusion During Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Beetroot Crystals (Nitrate)', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.\n\nSuper Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo (Beetroot Powder, no Nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.\n\nSuper Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks'}, {'id': 'OG002', 'title': 'Nondiabetic Control Subjects', 'description': "All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation."}], 'classes': [{'title': 'Forearm Blood Flow - pre supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '156', 'spread': '69', 'groupId': 'OG000'}, {'value': '143', 'spread': '69', 'groupId': 'OG001'}, {'value': '200', 'spread': '64', 'groupId': 'OG002'}]}]}, {'title': 'Forearm Blood Flow - post supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '175', 'spread': '73', 'groupId': 'OG000'}, {'value': '143', 'spread': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre and post 8 weeks of dietary nitrate supplementation', 'description': 'Forearm blood flow will be determined using Doppler ultrasound during rhythmic forearm exercise.', 'unitOfMeasure': 'ml/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Nondiabetic control subjects only completed rhythmic forearm exercise and forearm blood flow measurements at one study visit (same time point as pre measurements for T2D subjects).'}, {'type': 'PRIMARY', 'title': 'Change in Skeletal Muscle Mitochondrial Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Beetroot Crystals (Nitrate)', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.\n\nSuper Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks'}, {'id': 'OG001', 'title': 'Placebo (Beetroot Powder, no Nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.\n\nSuper Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks'}, {'id': 'OG002', 'title': 'Nondiabetic Control Subjects', 'description': "All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation."}], 'classes': [{'title': 'CHO-supported respiration - Pre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '64.6', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '71.0', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '87.5', 'spread': '21.5', 'groupId': 'OG002'}]}]}, {'title': 'CHO-supported respiration - Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.4', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '59.8', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre and post 8 weeks of dietary nitrate supplementation', 'description': 'Muscle biopsies were obtained from the vastus lateralis using a Bergstrom needle with suction under local anesthesia, which will yield \\~200-250mg of tissue. Mitochondrial function was assessed as follows: Fiber bundles were chemically permeabilized with saponin and mitochondrial respiration was analyzed by in situ high-resolution respirometry at 37°.', 'unitOfMeasure': 'Oxygen Flux, JO2 (pmol/(s*mg))', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Final number of participants studied with muscle biopsies was smaller than the total number of subjects enrolled in the study. The lower number was influenced by: (i) subjects not consenting to the muscle biopsy procedure; or (ii) technical problems (ex: not enough muscle tissue and/or extensive proportion of intramuscular fat obtained).\n\nNondiabetic control subjects only had muscle biopsies performed at one time point (same time point as pre measurements for T2D subjects).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Beetroot Crystals (Nitrate)', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.\n\nSuper Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks'}, {'id': 'FG001', 'title': 'Placebo (Beetroot Powder, no Nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.\n\nSuper Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks'}, {'id': 'FG002', 'title': 'Nondiabetic Control Subjects', 'description': "All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Beetroot Crystals (Nitrate)', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.\n\nSuper Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks'}, {'id': 'BG001', 'title': 'Placebo (Beetroot Powder, no Nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.\n\nSuper Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks'}, {'id': 'BG002', 'title': 'Nondiabetic Control Subjects', 'description': "All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '58.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '60.2', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '59.2', 'spread': '9.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-07', 'size': 617901, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-01T10:37', 'hasProtocol': True}, {'date': '2022-11-07', 'size': 96582, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-01T10:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2016-06-14', 'resultsFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-07', 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal Exercise Capacity (VO2max)', 'timeFrame': 'Pre and post 8 weeks of dietary nitrate supplementation', 'description': 'A 12-lead ECG, symptom limited cardiopulmonary exercise testing with gas exchange measurements will be performed on a cycle ergometer using a ramp protocol to determine maximal aerobic capacity (VO2max) and exercise efficiency.'}, {'measure': 'Change in Skeletal Muscle Perfusion During Exercise', 'timeFrame': 'Pre and post 8 weeks of dietary nitrate supplementation', 'description': 'Forearm blood flow will be determined using Doppler ultrasound during rhythmic forearm exercise.'}, {'measure': 'Change in Skeletal Muscle Mitochondrial Function', 'timeFrame': 'Pre and post 8 weeks of dietary nitrate supplementation', 'description': 'Muscle biopsies were obtained from the vastus lateralis using a Bergstrom needle with suction under local anesthesia, which will yield \\~200-250mg of tissue. Mitochondrial function was assessed as follows: Fiber bundles were chemically permeabilized with saponin and mitochondrial respiration was analyzed by in situ high-resolution respirometry at 37°.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '36326473', 'type': 'DERIVED', 'citation': 'Bock JM, Hanson BE, Miller KA, Seaberg NT, Ueda K, Feider AJ, Hanada S, Lira VA, Casey DP. Eight weeks of inorganic nitrate/nitrite supplementation improves aerobic exercise capacity and the gas exchange threshold in patients with type 2 diabetes. J Appl Physiol (1985). 2022 Dec 1;133(6):1407-1414. doi: 10.1152/japplphysiol.00478.2022. Epub 2022 Nov 3.'}, {'pmid': '35639721', 'type': 'DERIVED', 'citation': 'Bock JM, Hughes WE, Ueda K, Feider AJ, Hanada S, Casey DP. Dietary Inorganic Nitrate/Nitrite Supplementation Reduces Central and Peripheral Blood Pressure in Patients With Type 2 Diabetes Mellitus. Am J Hypertens. 2022 Sep 1;35(9):803-809. doi: 10.1093/ajh/hpac068.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use a randomized, double-blind, placebo controlled study design to comprehensively investigate the impact of 8-weeks of dietary nitrate supplementation on skeletal muscle blood flow, mitochondrial function, and exercise capacity in patients with type 2 diabetes (T2D).', 'detailedDescription': 'Patients with type 2 diabetes (T2D) demonstrate a reduced exercise capacity, a powerful predictor of cardiovascular mortality, which may be due to reductions in skeletal muscle perfusion and mitochondrial dysfunction. Nitric oxide (NO) is a key molecule involved in in the regulation of blood flow to contracting muscles, as well as a critical mediator in mitochondrial respiration. However, there appears to be a decreased enzymatic synthesis of NO and an overall reduction of bioavailable NO in patients with T2D, which likely contributes to the reduced exercise capacity and tolerance. Accumulating evidence suggests that exogenous nitrate supplementation is an effective option for increasing NO bioavailability in vivo. The purpose of the proposal is to use a randomized, double-blind, placebo controlled study design to comprehensively investigate the impact of 8-weeks of dietary nitrate supplementation on skeletal muscle blood flow, mitochondrial function, and exercise capacity in patients with T2D. The central hypothesis is that increasing NO bioavailability via dietary nitrate supplementation in patients with T2D will lead to improved oxygen delivery and utilization during exercise. To address this hypothesis a highly mechanistic and translational experimental strategy will be used to explore whether increased NO bioavailability via dietary nitrate supplementation improves skeletal muscle perfusion during exercise (Aim 1), enhances mitochondrial biogenesis and function (Aim 2), and improves exercise capacity and efficiency (Aim 3). Collectively, these studies will provide important mechanistic insight into the therapeutic potential of dietary nitrate supplementation for improving skeletal muscle blood flow, mitochondrial function and exercise capacity in patients with T2D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For 50 patients with documented Type 2 diabetes\n\nInclusion Criteria:\n\n* Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.\n* Age is \\> or = 40 and \\< or = 77 years of age\n* Documented Type 2 diabetes\n\nExclusion Criteria:\n\n* diagnosis of type 2 diabetes \\< 3 years prior to enrollment\n* HbA1c \\<6.0% or \\>10.0%\n* body mass index \\> 42 kg/m2\n* incident cardiovascular events in the last year (heart attack, stroke)\n* symptomatic coronary artery disease and/or heart failure\n* uncontrolled hypertension\n* hypotension (resting systolic BP \\< 90 mmHg)\n* renal impairment with creatinine clearance (eGFR) of \\<50 ml/min\n* smoking or history of smoking within past one year\n* use of medication which contain nitrates\n* use of anti-coagulant drugs\n* use of anti-platelet drugs\n* participation in research studies in which medications or interventions are given which would potentially alter subject responses in the current study\n\nFor 15 age- and weight-matched nondiabetic control subjects\n\nInclusion Criteria:\n\n* Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.\n* Age is \\> or = 40 and \\< or = 77 years of age\n\nExclusion Criteria:\n\n* Diagnosis of diabetes (Type 1 or Type 2)\n* body mass index \\> 42 kg/m2\n* incident cardiovascular events in the last year (heart attack, stroke)\n* symptomatic coronary artery disease and/or heart failure\n* uncontrolled hypertension\n* hypotension (resting systolic BP \\< 90 mmHg)\n* renal impairment with creatinine clearance (eGFR) of \\<50 ml/min\n* smoking or history of smoking within past one year\n* use of medication which contain nitrates\n* use of anti-coagulant drugs\n* use of anti-platelet drugs\n* participation in research studies in which medications or interventions are given which would potentially alter subject responses in the current study'}, 'identificationModule': {'nctId': 'NCT02804932', 'briefTitle': 'Nitrate Supplementation and Exercise Tolerance in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Nitrate Supplementation and Exercise Tolerance in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '201511802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beetroot crystals (nitrate)', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.', 'interventionNames': ['Dietary Supplement: Super Beets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (beetroot powder, no nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.', 'interventionNames': ['Other: Super Beets Placebo']}], 'interventions': [{'name': 'Super Beets', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beetroot crystals'], 'description': 'Nitrate rich beetroot powder (10g/day) for 8 weeks', 'armGroupLabels': ['Beetroot crystals (nitrate)']}, {'name': 'Super Beets Placebo', 'type': 'OTHER', 'otherNames': ['Beetroot crystals no nitrate'], 'description': 'Nitrate deficient beetroot powder (10g/day) for 8 weeks', 'armGroupLabels': ['Placebo (beetroot powder, no nitrate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Darren P Casey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Darren P Casey', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Darren P Casey', 'investigatorAffiliation': 'University of Iowa'}}}}