Diabetes Mellitus, ExperimentalERGENCT04488848
Cardiometabolic Effects of Rapid Glucose Excursion
A study testing bolus glucose and continuous clucose in people with Diabetes Mellitus, Experimental, run by Barmherzige Brüder Linz at 1 site in Austria.
Trial summary
The effects of rapid glucose excursions, induced by intravenous bolus application of glucose in healthy probands, on cardiometabolic and inflammatory parameters will be investigated Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Experimental
- What is being tested?
- bolus glucose and continuous clucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 11 Apr 2019to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 18 years or older with no disease history
- written informed consent
Who cannot join
- receiving any medication
- probands who suffer from infectious disease
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Barmherzige Brüder Linz - Innere Medizin
Linz, 4021
Matthias Heinzl, +436765206829, matthias.heinzl@bblinz.at
About this study
Official title: Effect of Rapid Glucose Excursion Versus Continuous Glucose Infusion on Cardiovascular and Metabolic Parameters in Healthy Volunteers
The effects of rapid glucose excursions, induced by intravenous bolus application of glucose in healthy probands, on cardiometabolic and inflammatory parameters will be investigated
Read the detailed description
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
- Diabetes Mellitus, Experimental
- Being tested
- bolus glucose, continuous clucose
- Medical subject headings
- Diabetes Mellitus, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bolus glucoseOther
bolus Glucose
continuous clucoseOther
continuous clucose
| Study group | Role | What they receive |
|---|---|---|
| continous glucose | Placebo comparator | continous glucose infusion (60 grams over 3 hours) Receives: Other: continuous clucose |
| bolus (excursion) | Experimental | 3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes Receives: Other: bolus glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6
measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start11 Apr 2019
- Primary completion31 Dec 2020
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, ExperimentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barmherzige Brüder Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488848
- Sponsor's protocol ID
- ERGE
- Acronym
- ERGE
- Status last verified
- Jan 2021
- First submitted
- 7 Aug 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36574434
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rapid Glucose Excursion Versus Continuous Glucose Infusion on Cardiovascular and Metabolic Parameters in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04488848
- Acronym / sponsor ID
- ERGE / ERGE
- Conditions
- Diabetes Mellitus, Experimental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Barmherzige Brüder LinzUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continous glucose | Placebo comparator | Other: continuous clucosecontinous glucose infusion (60 grams over 3 hours) |
| bolus (excursion) | Experimental | Other: bolus glucose3 x 20 grams of glucose as a bolus over 6 minutes at t0, 60 minutes and 120 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men aged 18 years or older with no disease history
- written informed consent
Key exclusion criteria (2 listed)
- receiving any medication
- probands who suffer from infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bolus glucosebolus Glucose | Other | bolus (excursion) |
| continuous clucosecontinuous clucose | Other | continous glucose |
Primary outcome
Interleukin-6
Time frame: 48 hours
measurement of the concentration of IL-6 (parameter of inflammation) in the serum over time following infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Derived from this study: PubMed 36574434Feldbauer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bolus glucose and continuous clucose in people with Diabetes Mellitus, Experimental, run by Barmherzige Brüder Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Heinzl, MD (+43732789721236, matthias.heinzl@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.