The Effect of Dietary Nitrate on Blood Pressure, Insulin Sensitivity, and Vascular Function in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT04076007|
Recruitment Status : Completed
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Hypertension||Dietary Supplement: Beetroot juice Dietary Supplement: Nitrate depleted beetroot juice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Dietary Nitrate on Blood Pressure, Insulin Resistance and Vascular Function in Type 2 Diabetes|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||February 2015|
Active Comparator: Active
Nitrate rich beetroot juice (7.5 mmol nitrate in 250mls beetroot juice) once daily.
Dietary Supplement: Beetroot juice
Placebo Comparator: Placebo
Nitrate depleted beetroot juice (0.002 mmol nitrate in 250 ml beetroot juice) once daily.
Dietary Supplement: Nitrate depleted beetroot juice
- 24 hour Ambulatory Blood Pressure monitoring after 2 weeks active juice [ Time Frame: 2 weeks ]24 hour average systolic, diastolic blood pressure in mm Hg
- 24 hour Ambulatory Blood Pressure monitoring after 2 weeks placebo juice [ Time Frame: 2 weeks ]24 hour average systolic, diastolic blood pressure in mm Hg
- Brachial artery Flow mediated vasodilation [ Time Frame: After 2 weeks active juice and after 2 weeks placebo juice ]Following release of a downstream occlusive cuff the percentage change from baseline in the diameter of the brachial artery is recorded.
- Microvascular response to Iontophoresis of Acetylcholine and Sodium Nitroprusside [ Time Frame: After 2 weeks active juice and after 2 weeks placebo juice ]Skin blood flux will be measured following iontophoresis of the vasodilators acetylcholine and sodium nitroprusside. Peak flux and area under the curve measured in arbitrary units of flux.
- Peak reactive hyperemia [ Time Frame: After 2 weeks active juice and after 2 weeks placebo juice ]Assessment of morphology of peak blood flow following release of occlusion of lower limb arterial supply. Measurements include time to peak blood flow (seconds), time to return to base line flow (seconds) and categorisation of peak shape.
- Maximum hyperemia in response to heating [ Time Frame: After 2 weeks active juice and after 2 weeks placebo juice ]Peak blood flux in skin in response to localised heating to 42 degrees C
- Cognitive function [ Time Frame: After 2 weeks active juice and after 2 weeks placebo juice ]E-prime software will be used to determine the percentage accuracy and response time in seconds to a six separate cognitive challenges
- Insulin sensitivity [ Time Frame: After 2 weeks active juice and after 2 weeks placebo juice ]A hyperinsulinemic isoglycaemic clamp will be used to determine the amount of glucose required to maintain isoglycaemia (mg/kg/min)
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|Ages Eligible for Study:||35 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Patients with type II diabetes (as defined by WHO) of at least 5 years duration between the ages of 35-75 known to have blood pressure above 125mmHg systolic and/or 85mmHg diastolic, or who are taking one or two antihypertensive drugs will be invited.
Healthy Control inclusion/exclusion criteria
- Age and sex matched for participants with diabetes
- Not on any regular medication, excluding the oral contraceptive pill
- Able to give informed consent
- Patients with significant renal impairment (eGFR<30), uncontrolled hypertension, BMI<25 or >35, are taking regular organic nitrates, nicorandil, glitazones, phosphodiesterase inhibitors, who have had a myocardial infarction or cerebro-vascular event, who smoke, or any other serious medical condition which would interfere with data interpretation or safety will be excluded
- Antibiotic therapy within the preceding two weeks
- Myocardial infarction or cerebro-vascular event within the preceding three months
- Current smoker
- Any other medical condition which would interfere with data interpretation or safety.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076007
|NIHR Exeter Clinical Research Facility|
|Exeter, Devon, United Kingdom, EX2 5DW|
|Principal Investigator:||Mark Gilchrist, MB ChB, PhD||University of Exeter|
|Responsible Party:||University of Exeter|
|Other Study ID Numbers:||
|First Posted:||September 3, 2019 Key Record Dates|
|Last Update Posted:||September 3, 2019|
|Last Verified:||August 2019|
Glucose Metabolism Disorders
Endocrine System Diseases