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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04917471
Other study ID # NOBLE-DM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source Karolinska Institutet
Contact John Pernow
Phone +46704848361
Email john.pernow@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Dietary Supplement:
Beet root juice
70 ml bid
Placebo juice
70 ml bid

Locations

Country Name City State
Sweden Karolinska Institutet, Karolinska University Hospital Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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