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RecruitingNCT04917471Updated Oct 9, 2024

Effect of Nitrate on Red Blood Cell Function in Type 2 Diabetes

An interventional study of Beet root juice and Placebo juice in Type 2 Diabetes, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Type 2 diabetes

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Nitrate-rich beet root juice

    Nitrate-rich Beet root juice 70 ml bid

    Dietary Supplement: Beet root juice

  • Placebo comparator
    Placebo

    Nitrate-depleted beet root juice 70 ml bid

    Dietary Supplement: Placebo juice

Interventions

  • Dietary supplementBeet root juice

    70 ml bid

  • Dietary supplementPlacebo juice

    70 ml bid

06

What researchers measure

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.

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Karolinska Institutet, Karolinska University Hospital
    Stockholm, 17176, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04917471
Lead sponsor
Karolinska Institutet
Responsible party
John Pernow (Professor, Karolinska Institutet) — Principal investigator
First posted
Jun 8, 2021
Start date
Jun 1, 2021
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Oct 9, 2024

Study contacts

John Pernow
Contact
john.pernow@ki.se
+46704848361
John Pernow
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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