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

March 27, 2023 updated by: John Pernow, Karolinska Institutet

The Effect of Dietary Nitrate Supplementation on Red Blood Cell Function in Patients With Type 2 Diabetes

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Karolinska Institutet, Karolinska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Type 2 diabetes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nitrate-rich beet root juice
Nitrate-rich Beet root juice 70 ml bid
Dietary supplement: Beet root juice
70 ml bid
Placebo Comparator: Placebo
Nitrate-depleted beet root juice 70 ml bid
Dietary supplement: Placebo juice
70 ml bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage recovery of left ventricular function
Time Frame: 1 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: John Pernow, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOBLE-DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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