NCT04076007

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 diabetes and age matched healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

June 2, 2015

Last Update Submit

August 30, 2019

Conditions

DiabetesHypertension

Keywords

nitratenitritenitric oxidediabeteshypertension

Outcome Measures

Primary Outcomes (2)

  • 24 hour Ambulatory Blood Pressure monitoring after 2 weeks active juice

    24 hour average systolic, diastolic blood pressure in mm Hg

    2 weeks

  • 24 hour Ambulatory Blood Pressure monitoring after 2 weeks placebo juice

    24 hour average systolic, diastolic blood pressure in mm Hg

    2 weeks

Secondary Outcomes (6)

  • Brachial artery Flow mediated vasodilation

    After 2 weeks active juice and after 2 weeks placebo juice

  • Microvascular response to Iontophoresis of Acetylcholine and Sodium Nitroprusside

    After 2 weeks active juice and after 2 weeks placebo juice

  • Peak reactive hyperemia

    After 2 weeks active juice and after 2 weeks placebo juice

  • Maximum hyperemia in response to heating

    After 2 weeks active juice and after 2 weeks placebo juice

  • Cognitive function

    After 2 weeks active juice and after 2 weeks placebo juice

  • +1 more secondary outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR

Nitrate rich beetroot juice (7.5 mmol nitrate in 250mls beetroot juice) once daily.

Dietary Supplement: Beetroot juice

Placebo

PLACEBO COMPARATOR

Nitrate depleted beetroot juice (0.002 mmol nitrate in 250 ml beetroot juice) once daily.

Dietary Supplement: Nitrate depleted beetroot juice

Interventions

Beetroot juiceDIETARY_SUPPLEMENT
Active
Nitrate depleted beetroot juiceDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mark Gilchrist, MB ChB, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2015

First Posted

September 3, 2019

Study Start

December 1, 2009

Primary Completion

August 1, 2012

Study Completion

February 1, 2015

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

GB(1)