Status:
COMPLETED
The Effect of Dietary Nitrate on Blood Pressure, Insulin Sensitivity, and Vascular Function in Type 2 Diabetes
Lead Sponsor:
University of Exeter
Conditions:
Diabetes
Hypertension
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief 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 diabe...
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, endothe...
Eligibility Criteria
Inclusion
- 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
- Inclusion criteria
- Age and sex matched for participants with diabetes
- Not on any regular medication, excluding the oral contraceptive pill
- Able to give informed consent
Exclusion
- 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
- Exclusion Criteria
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04076007
Start Date
December 1 2009
End Date
February 1 2015
Last Update
September 3 2019
Active Locations (1)
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1
NIHR Exeter Clinical Research Facility
Exeter, Devon, United Kingdom, EX2 5DW