DiabetesNCT04076007
The Effect of Dietary Nitrate on Blood Pressure, Insulin Sensitivity, and Vascular Function in Type 2 Diabetes
A study testing Beetroot juice and Nitrate depleted beetroot juice in people with Diabetes and Hypertension, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Dietary nitrate supplementation has previously been shown to reduce blood pressure in healthy volunteers. The investigators wished to see whether this would be replicated in subjects with type 2 diabetes and age matched healthy controls. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- Beetroot juice and Nitrate depleted beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Exeter Clinical Research Facility
Exeter, Devon, EX2 5DW
About this study
Official title: The Effect of Dietary Nitrate on Blood Pressure, Insulin Resistance and Vascular Function in Type 2 Diabetes
Dietary nitrate supplementation has previously been shown to reduce blood pressure in healthy volunteers. The investigators wished to see whether this would be replicated in subjects with type 2 diabetes and age matched healthy controls.
Read the detailed description
Double blind, randomised placebo control trial, with crossover design comparing the effect of beetroot juice (rich in nitrate) with placebo (nitrate depleted beetroot juice) on blood pressure, endothelial function and insulin sensitivity in subjects with type 2 diabetes. Healthy age matched subjects will have blood pressure measured.
Plan of Investigations: Study outcome measurements.
Blood pressure measured using ambulatory blood pressure monitoring (Spacelabs) for 24 hours.
Urine albumin excretion rate: in overnight samples using standard radioimmunoassay techniques.
Urine nitrate excretion will be used as a measure of adherence, and will be measured using an HPLC assay recently developed at St. Luke's in Professor Winyard's laboratory.
Microvascular endothelial function assessed by iontophoresis of an endothelial -dependent (acetylcholine, ACh) and -independent (sodium nitroprusside, SNP) vasodilator and monitoring of perfusion response using Laser Doppler Perfusion Imaging intra-individual coefficient of variation is 12% for Ach and 18.7% for SNP.
Post-occlusive reactive hyperaemia: A laser Doppler probe will be attached to the inside surface of the forearm or the dorsum of the foot and blood flow will be measured for 5-minutes. Following this, a blood pressure cuff will be rapidly inflated to 200mmHg for 5 minutes to occlude blood flow. At the end of the 4 minute occlusion the cuff will be rapidly deflated and blood flow recorded for 10 minutes post release. This procedure stimulates microvessels to dilate with a consequent increase in blood flow. Analysis involves detailed investigation into the shape of the blood flow curve in order to categorize it into one of 3 options: normal; early dominant peak and early non-dominant peak.
Optical reflectance spectroscopy (ORS) ORS is a non-invasive technique that directly measures both the changes in blood volume and oxygenation of the skin microcirculation. Visible light passing through the skin is attenuated in part by the concentration of oxy- and deoxyhaemoglobin. Assuming the attenuation of light by scattering remains constant, changes in the concentration of oxy- and deoxyhaemoglobin can be calculated from the measured changes in light attenuation at different wavelengths as it travels through the skin.
Skin Maximum Hyperaemia (MH): An area of the dorsal aspect of the right foot and the ventral aspect of the forearm, clear of visible veins or skin lesions, will be heated to a temperature of 42C for 30 minutes with a small brass heater of 1cm in diameter (Moor Instruments, Axminster, Devon, U.K.) and the maximum blood flow response is measured using laser Doppler techniques (single point or laser Doppler perfusion imager. The mean intra-individual coefficient of variation for the measurement of maximum blood flow is 6.6% determined from 2 subjects on 5 separate occasions. Using this technique the investigators have previously observed alterations in skin maximum hyperaemia with type 2 diabetes and in women with a previous history of gestational diabetes.
Near-infrared spectroscopy (NIRS). NIRS is a non-invasive technique that assesses the change in blood volume and oxygenation of the microcirculation in different tissue beds including muscle and brain., it works on the same principles of ORS except that it uses a near-infrared light source rather then visible light. As near-infrared (760 - 840 nm) has a longer wavelength than visible light it scatter less and therefore it has an increased depth of penetration which allows it to assess oxygenation in the muscle or brain where it will be used in relation to our assessment of cognition.
. Insulin sensitivity will be measured at the end of the two treatment phases using a hyper-insulinaemic isoglycaemic clamp (a modified version of the hyperinsulinaemic euglycaemic clamp). A primed, constant rate infusion of soluble insulin (2.0 mukg per min) will be administered for 180min and a variable rate infusion of 20% glucose administered to maintain isoglycaemia . The isoglycaemic set point will be determined by taking the mean of two fasting blood glucose measurements which will be taken on the day of vascular testing and prior to the clamp. The insulin infusion will be prepared in 45 ml of 0.9% NaCI, and 5 ml of the patient's blood to prevent adsorption of insulin to plastic surfaces. At 5 min intervals, 2 ml blood samples will be collected from a dorsal hand vein. During steady state, M is calculated from glucose infusion rate and serum insulin concentration according to a simple mathematical formula.
Flow mediated vasodilatation used as a measure of the production of endothelial nitric oxide to a standard stimulus (shear). As described previously and following consensus guidelines, peripheral vascular endothelium-dependent (i.e. NO-mediated) vasodilatation in response to forearm reactive hyperaemia will be determined by measuring the diameter change of the brachial artery using linear array B-mode ultrasound and automated edge detection software (MIA, Iowa, USA). Reactive hyperaemia will be induced by occlusion of blood flow to the upper forearm using a cuff inflated to 250 mmHg for 5 minutes followed by rapid deflation. Blood flow during reactive hyperaemia will be measured using an Ultrasound Doppler system for the calculation and analysis of the shear-rate stimulus. Vascular endothelium-independent vasodilatation (internal control) will be determined by the brachial artery dilatation to sublingual nitroglycerine (0.4 mg). The intra-individual coefficient of variation for flow mediated dilatation is 8.1%.
VO2 max testing: Static bicycle exercise tests will be performed to determine oxygen uptake kinetics during sub-maximal exercise and maximal oxygen uptake using standard procedures. During the exercise tests, near infra-red spectroscopy will be used to measure the changes in muscle oxy, deoxy and total haemoglobin which accompany exercise.
Cognitive Function Testing: Using the E-prime program (Psychology Software Tools inc) a 30 minute array of cognitive function tests will be devised. The patient will complete these simple tests on a laptop during the acclimatisation period
Plasma Nitrite and Nitrate Deproteinised samples will be analysed for nitrite and nitrate concentration using a Sievers nitric oxide analyser (Sievers NOA 280i, Analytix Ltd, Durham, UK) and a modification of our previous chemiluminescence technique
- Conditions
- Diabetes, Hypertension
- Being tested
- Beetroot juice, Nitrate depleted beetroot juice
- Keywords
- nitrate, nitrite, nitric oxide, diabetes, hypertension
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
Nitrate depleted beetroot juiceDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Nitrate rich beetroot juice (7.5 mmol nitrate in 250mls beetroot juice) once daily. Receives: Dietary Supplement: Beetroot juice |
| Placebo | Placebo comparator | Nitrate depleted beetroot juice (0.002 mmol nitrate in 250 ml beetroot juice) once daily. Receives: Dietary Supplement: Nitrate depleted beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour Ambulatory Blood Pressure monitoring after 2 weeks active juice
24 hour average systolic, diastolic blood pressure in mm Hg
Measured: 2 weeks
24 hour Ambulatory Blood Pressure monitoring after 2 weeks placebo juice
24 hour average systolic, diastolic blood pressure in mm Hg
Measured: 2 weeks
Secondary outcomes (6)
Brachial artery Flow mediated vasodilation
Following release of a downstream occlusive cuff the percentage change from baseline in the diameter of the brachial artery is recorded.
Measured: After 2 weeks active juice and after 2 weeks placebo juice
Microvascular response to Iontophoresis of Acetylcholine and Sodium Nitroprusside
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.
Measured: After 2 weeks active juice and after 2 weeks placebo juice
Peak reactive hyperemia
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.
Measured: After 2 weeks active juice and after 2 weeks placebo juice
Maximum hyperemia in response to heating
Peak blood flux in skin in response to localised heating to 42 degrees C
Measured: After 2 weeks active juice and after 2 weeks placebo juice
Cognitive function
E-prime software will be used to determine the percentage accuracy and response time in seconds to a six separate cognitive challenges
Measured: After 2 weeks active juice and after 2 weeks placebo juice
Insulin sensitivity
A hyperinsulinemic isoglycaemic clamp will be used to determine the amount of glucose required to maintain isoglycaemia (mg/kg/min)
Measured: After 2 weeks active juice and after 2 weeks placebo juice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study startDec 2009
- Primary completionAug 2012
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Gilchrist, MB ChB, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076007
- Sponsor's protocol ID
- CRF035
- Status last verified
- Aug 2019
- First submitted
- 2 Jun 2015
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Nitrate on Blood Pressure, Insulin Resistance and Vascular Function in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04076007
- Acronym / sponsor ID
- CRF035
- Conditions
- Diabetes, Hypertension
- Keywords
- nitrate, nitrite, nitric oxide, diabetes, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dietary nitrate supplementation has previously been shown to reduce blood pressure in healthy volunteers. The investigators wished to see whether this would be replicated in subjects with type 2 diabetes and age matched healthy controls.
Detailed description
Double blind, randomised placebo control trial, with crossover design comparing the effect of beetroot juice (rich in nitrate) with placebo (nitrate depleted beetroot juice) on blood pressure, endothelial function and insulin sensitivity in subjects with type 2 diabetes. Healthy age matched subjects will have blood pressure measured.
Plan of Investigations: Study outcome measurements.
Blood pressure measured using ambulatory blood pressure monitoring (Spacelabs) for 24 hours.
Urine albumin excretion rate: in overnight samples using standard radioimmunoassay techniques.
Urine nitrate excretion will be used as a measure of adherence, and will be measured using an HPLC assay recently developed at St. Luke's in Professor Winyard's laboratory.
Microvascular endothelial function assessed by iontophoresis of an endothelial -dependent (acetylcholine, ACh) and -independent (sodium nitroprusside, SNP) vasodilator and monitoring of perfusion response using Laser Doppler Perfusion Imaging intra-individual coefficient of variation is 12% for Ach and 18.7% for SNP.
Post-occlusive reactive hyperaemia: A laser Doppler probe will be attached to the inside surface of the forearm or the dorsum of the foot and blood flow will be measured for 5-minutes. Following this, a blood pressure cuff will be rapidly inflated to 200mmHg for 5 minutes to occlude blood flow. At the end of the 4 minute occlusion the cuff will be rapidly deflated and blood flow recorded for 10 minutes post release. This procedure stimulates microvessels to dilate with a consequent increase in blood flow. Analysis involves detailed investigation into the shape of the blood flow curve in order to categorize it into one of 3 options: normal; early dominant peak and early non-dominant peak.
Optical reflectance spectroscopy (ORS) ORS is a non-invasive technique that directly measures both the changes in blood volume and oxygenation of the skin microcirculation. Visible light passing through the skin is attenuated in part by the concentration of oxy- and deoxyhaemoglobin. Assuming the attenuation of light by scattering remains constant, changes in the concentration of oxy- and deoxyhaemoglobin can be calculated from the measured changes in light attenuation at different wavelengths as it travels through the skin.
Skin Maximum Hyperaemia (MH): An area of the dorsal aspect of the right foot and the ventral aspect of the forearm, clear of visible veins or skin lesions, will be heated to a temperature of 42C for 30 minutes with a small brass heater of 1cm in diameter (Moor Instruments, Axminster, Devon, U.K.) and the maximum blood flow response is measured using laser Doppler techniques (single point or laser Doppler perfusion imager. The mean intra-individual coefficient of variation for the measurement of maximum blood flow is 6.6% determined from 2 subjects on 5 separate occasions. Using this technique the investigators have previously observed alterations in skin maximum hyperaemia with type 2 diabetes and in women with a previous history of gestational diabetes.
Near-infrared spectroscopy (NIRS). NIRS is a non-invasive technique that assesses the change in blood volume and oxygenation of the microcirculation in different tissue beds including muscle and brain., it works on the same principles of ORS except that it uses a near-infrared light source rather then visible light. As near-infrared (760 - 840 nm) has a longer wavelength than visible light it scatter less and therefore it has an increased depth of penetration which allows it to assess oxygenation in the muscle or brain where it will be used in relation to our assessment of cognition.
. Insulin sensitivity will be measured at the end of the two treatment phases using a hyper-insulinaemic isoglycaemic clamp (a modified version of the hyperinsulinaemic euglycaemic clamp). A primed, constant rate infusion of soluble insulin (2.0 mukg per min) will be administered for 180min and a variable rate infusion of 20% glucose administered to maintain isoglycaemia . The isoglycaemic set point will be determined by taking the mean of two fasting blood glucose measurements which will be taken on the day of vascular testing and prior to the clamp. The insulin infusion will be prepared in 45 ml of 0.9% NaCI, and 5 ml of the patient's blood to prevent adsorption of insulin to plastic surfaces. At 5 min intervals, 2 ml blood samples will be collected from a dorsal hand vein. During steady state, M is calculated from glucose infusion rate and serum insulin concentration according to a simple mathematical formula.
Flow mediated vasodilatation used as a measure of the production of endothelial nitric oxide to a standard stimulus (shear). As described previously and following consensus guidelines, peripheral vascular endothelium-dependent (i.e. NO-mediated) vasodilatation in response to forearm reactive hyperaemia will be determined by measuring the diameter change of the brachial artery using linear array B-mode ultrasound and automated edge detection software (MIA, Iowa, USA). Reactive hyperaemia will be induced by occlusion of blood flow to the upper forearm using a cuff inflated to 250 mmHg for 5 minutes followed by rapid deflation. Blood flow during reactive hyperaemia will be measured using an Ultrasound Doppler system for the calculation and analysis of the shear-rate stimulus. Vascular endothelium-independent vasodilatation (internal control) will be determined by the brachial artery dilatation to sublingual nitroglycerine (0.4 mg). The intra-individual coefficient of variation for flow mediated dilatation is 8.1%.
VO2 max testing: Static bicycle exercise tests will be performed to determine oxygen uptake kinetics during sub-maximal exercise and maximal oxygen uptake using standard procedures. During the exercise tests, near infra-red spectroscopy will be used to measure the changes in muscle oxy, deoxy and total haemoglobin which accompany exercise.
Cognitive Function Testing: Using the E-prime program (Psychology Software Tools inc) a 30 minute array of cognitive function tests will be devised. The patient will complete these simple tests on a laptop during the acclimatisation period
Plasma Nitrite and Nitrate Deproteinised samples will be analysed for nitrite and nitrate concentration using a Sievers nitric oxide analyser (Sievers NOA 280i, Analytix Ltd, Durham, UK) and a modification of our previous chemiluminescence technique
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Beetroot juiceNitrate rich beetroot juice (7.5 mmol nitrate in 250mls beetroot juice) once daily. |
| Placebo | Placebo comparator | Dietary Supplement: Nitrate depleted beetroot juiceNitrate depleted beetroot juice (0.002 mmol nitrate in 250 ml beetroot juice) once daily. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juice | Dietary supplement | Active |
| Nitrate depleted beetroot juice | Dietary supplement | Placebo |
Primary outcome
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
6 secondary outcomes
Brachial artery Flow mediated vasodilation
Time frame: After 2 weeks active juice and after 2 weeks placebo juice
Microvascular response to Iontophoresis of Acetylcholine and Sodium Nitroprusside
Time frame: After 2 weeks active juice and after 2 weeks placebo juice
Peak reactive hyperemia
Time frame: After 2 weeks active juice and after 2 weeks placebo juice
Maximum hyperemia in response to heating
Time frame: After 2 weeks active juice and after 2 weeks placebo juice
Cognitive function
Time frame: After 2 weeks active juice and after 2 weeks placebo juice
Insulin sensitivity
Time frame: After 2 weeks active juice and after 2 weeks placebo juice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Gilchrist, MB ChB, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice and Nitrate depleted beetroot juice in people with Diabetes and Hypertension, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour Ambulatory Blood Pressure monitoring after 2 weeks active juice (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.