Back to resultsEffect of Nitrate on Red Blood Cell Function in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Beet root juice
Placebo juice
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes
Eligibility Criteria
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
Sites / Locations
- Karolinska Institutet, Karolinska University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nitrate-rich beet root juice
Placebo
Arm Description
Nitrate-rich Beet root juice 70 ml bid
Nitrate-depleted beet root juice 70 ml bid
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04917471
Brief Title
Effect of Nitrate on Red Blood Cell Function in Type 2 Diabetes
Official Title
The Effect of Dietary Nitrate Supplementation on Red Blood Cell Function in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of nitrate supplementation on red blood cell function in patients with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitrate-rich beet root juice
Arm Type
Active Comparator
Arm Description
Nitrate-rich Beet root juice 70 ml bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nitrate-depleted beet root juice 70 ml bid
Intervention Type
Dietary Supplement
Intervention Name(s)
Beet root juice
Intervention Description
70 ml bid
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo juice
Intervention Description
70 ml bid
Primary Outcome Measure Information:
Title
Percentage recovery of left ventricular function
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Pernow
Phone
+46704848361
Email
john.pernow@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Pernow
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Pernow, Dr
Phone
+46851775876
Email
john.pernow@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Nitrate on Red Blood Cell Function in Type 2 Diabetes
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