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

Sponsor

Karolinska Institutet (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04917471

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Dietary Supplement: Beet root juice Dietary Supplement: Placebo juice	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage recovery of left ventricular function [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet, Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator: John Pernow, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

John Pernow, Professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT04917471

Other Study ID Numbers:

NOBLE-DM

First Posted:

Jun 8, 2021

Last Update Posted:

Jun 8, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jun 8, 2021