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

NCT ID: NCT04917471

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nitrate-rich beet root juice

Nitrate-rich Beet root juice 70 ml bid

Group Type ACTIVE_COMPARATOR

Beet root juice

Intervention Type DIETARY_SUPPLEMENT

70 ml bid

Placebo

Nitrate-depleted beet root juice 70 ml bid

Group Type PLACEBO_COMPARATOR

Placebo juice

Intervention Type DIETARY_SUPPLEMENT

70 ml bid

Interventions

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Beet root juice

70 ml bid

Intervention Type DIETARY_SUPPLEMENT

Placebo juice

70 ml bid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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John Pernow

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Pernow

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet, Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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John Pernow

Role: CONTACT

+46704848361

Facility Contacts

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John Pernow, Dr

Role: primary

+46851775876

Other Identifiers

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NOBLE-DM

Identifier Type: -

Identifier Source: org_study_id

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