Cardiometabolic Effects of Rapid Glucose Excursion

NCT ID: NCT04488848

Last Updated: 2021-01-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-11

Study Completion Date

2021-07-31

Brief Summary

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The effects of rapid glucose excursions, induced by intravenous bolus application of glucose in healthy probands, on cardiometabolic and inflammatory parameters will be investigated

Detailed Description

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BACKGROUND: It is well known that people with diabetes have a five times higher risk of dying of cardiovascular death than non-diabetics. However not only hyperglycaemia per se but also glycaemic variability is currently particularly regarded as a risk factor for cardiovascular and microvascular complications. Intermittent blood sugar excursions with pronounced fluctuations between high and low values instead of constant, even increased blood sugar exposure, have been shown to be more harmful in several studies.

AIM: The aim of this study is to determine the effect of rapid glucose excursion versus continuous glucose infusion on cardiovascular and metabolic parameters in healthy volunteers.

METHODS/DESIGN: In this study, ten healthy male subjects will be studied on two occasions. In a random order the subjects will receive 3 times 20 grams of glucose intravenously as a bolus or, on the other occasion, 60 grams of glucose continuously over 3 hours. Cardiometabolic biomarkers will be analysed serially to analyse the effects of glucose excursions.

PROSPECT: Glycaemic variability may be a crucial factor in the development of diabetic complications, but there is currently a lack of conclusive evidence. The causes and mechanisms of these negative influences on the cardiovascular system due to high glucose variability have not been sufficiently investigated and are therefore not fully understood so far. To date, however, there have been no studies with acutely altered glucose concentrations in healthy volunteers that have investigated the effects on traditional as well as recently identified cardiovascular and metabolic biomarkers. Knowledge of such effects may improve the therapeutic strategy in diabetic patients.

Conditions

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Diabetes Mellitus, Experimental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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continous glucose

continous glucose infusion (60 grams over 3 hours)

Group Type PLACEBO_COMPARATOR

continuous clucose

Intervention Type OTHER

continuous clucose

bolus (excursion)

3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes

Group Type EXPERIMENTAL

bolus glucose

Intervention Type OTHER

bolus Glucose

Interventions

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bolus glucose

bolus Glucose

Intervention Type OTHER

continuous clucose

continuous clucose

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men aged 18 years or older with no disease history
* written informed consent

Exclusion Criteria

* receiving any medication
* probands who suffer from infectious disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Barmherzige Brüder Linz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barmherzige Brüder Linz - Innere Medizin

Linz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Matthias Heinzl, MD

Role: CONTACT

+43732789721236

Martin Clodi, MD, Prof.

Role: CONTACT

+43732789724305

Facility Contacts

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Matthias Heinzl

Role: primary

+436765206829

References

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Feldbauer R, Heinzl MW, Klammer C, Resl M, Pohlhammer J, Rosenberger K, Almesberger V, Obendorf F, Schinagl L, Wagner T, Egger M, Dieplinger B, Clodi M. Effect of repeated bolus and continuous glucose infusion on a panel of circulating biomarkers in healthy volunteers. PLoS One. 2022 Dec 27;17(12):e0279308. doi: 10.1371/journal.pone.0279308. eCollection 2022.

Reference Type DERIVED
PMID: 36574434 (View on PubMed)

Other Identifiers

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ERGE

Identifier Type: -

Identifier Source: org_study_id

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