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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Placebo juice; Dietary Supplement: Beet root juice

• Registration Number: NCT04917471
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-05-25
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Type 2 diabetes

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo juice	Nitrate-depleted beet root juice 70 ml bid
Nitrate-rich beet root juice	Beet root juice	Nitrate-rich Beet root juice 70 ml bid

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Karolinska Institutet, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden