NCT04917471

Brief Summary

To investigate the effect of nitrate supplementation on red blood cell function in patients with type 2 diabetes.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

4.6 years

First QC Date

May 25, 2021

Last Update Submit

October 7, 2024

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage recovery of left ventricular function

    Red blood cells are administered to an isolated rodent heart subjected to 25 min global ischemia and 60 min reperfusion. The percentage recovery during reperfusion is determined.

    1 week

Study Arms (2)

Nitrate-rich beet root juice

ACTIVE COMPARATOR

Nitrate-rich Beet root juice 70 ml bid

Dietary Supplement: Beet root juice

Placebo

PLACEBO COMPARATOR

Nitrate-depleted beet root juice 70 ml bid

Dietary Supplement: Placebo juice

Interventions

Beet root juiceDIETARY_SUPPLEMENT

70 ml bid

Nitrate-rich beet root juice
Placebo juiceDIETARY_SUPPLEMENT

70 ml bid

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes

You may not qualify if:

  • Acute coronary syndrome Vegetarian diet Impaired renal function Absolute indication for proton pump inhibitor Ongoing treatment with organic nitrate Heart failure (ejection fraction \<35%) Any condition that interferes with the possibility to fulfill the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • John Pernow

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Pernow

CONTACT

+46704848361john.pernow@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 8, 2021

Study Start

June 1, 2021

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)