HyperglycemiaEarly Phase 1GlucoxNCT02346149
Effect of Acute Hyperglycemia on Renal Tissue Oxygenation
A Early Phase 1 study testing glucose 20% in people with Hyperglycemia and Glucose Intolerance, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Diabetes Mellitus (DM) includes several metabolic diseases all characterized by high sugar levels in the blood. Although diabetic nephropathy is widespread, its underlying pathophysiological mechanisms remain poorly understood and, so far, little progress has been made to prevent the development of diabetic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Glucose Intolerance
- What is being tested?
- glucose 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to 31 Jan 2019
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive family history of diabetes
- BMI > 25 kg / m2
- eGFR > 60 ml / min / 1.73 m2
- Understanding and signing the informed consent
Who cannot join
- Documented cardiac disease
- Documented liver failure
- Renal malformations, kidney diseases or documented renal artery stenosis
- History of organ transplantation
- Significant comorbidities compromising life expectancy
- Anemia
Show all 12Show fewer
- Type 1 or 2 diabetes
- Psychiatric illness
- Contraindication to MRI
- Pregnancy or breastfeeding
- Chronic drug intake such as antihypertensive (except for beta blockers and calcium antagonists), non steroidal anti-inflammatory drugs, diuretics or oral antidiabetics
- Blood donation 2 months before the MRI investigation day
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Nephrology, Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Effect of Acute Hyperglycemia on Renal Tissue Oxygenation as Measured By BOLD-MRI in Individuals With Impaired Glucose Tolerance and Controls
Diabetes Mellitus (DM) includes several metabolic diseases all characterized by high sugar levels in the blood. Although diabetic nephropathy is widespread, its underlying pathophysiological mechanisms remain poorly understood and, so far, little progress has been made to prevent the development of diabetic nephropathy and to delay kidney functions decline.
Increasing amount of data based on animal studies support the pathogenic role of tissue hypoxia in the development and progression of diabetic nephropathy. Blood Oxygenation-Level Dependent Magnetic Resonance Imaging (BOLD-MRI) is increasingly used in research to measure cortical and medullary oxygenation in a non-invasive manner. Interestingly, in two cross-sectional clinical studies, we have recently found a positive correlation between high circulating blood glucose levels and cortical R2* levels in type 2 DM patients. This discovery suggests that an increase in glycemia might acutely decrease renal tissue oxygenation.
The goal of this study is to investigate the impact of serum glucose on renal tissue oxygenation in healthy subjects and subjects with glucose intolerance.
Read the detailed description
Therefore, we plan to recruit 10 healthy subjects and 10 glucose intolerant patients with preserved kidney functions and to perform repetitive BOLD-MRI, before and after the administration of IV glucose. This will allow us to study the influence of hyperglycemia as a single factor, regardless of inflammation, oxidative stress and medical treatments, such as oral hypoglycemic agents and/or insulin, which are confounding factors present in all DM patients.
The main hypothesis of the project is that acute hyperglycemia could be partially responsible for renal tissue hypoxia detected in diabetic nephropathy cases.
In this study we will include 60 participants with a family history of diabetes, with a Body Mass Index (BMI) over 25 kg / m2 and/or having glucose intolerance. Each participant will undergo an initial glucose tolerance test. In total, we will select 10 participants with impaired glucose tolerance and 10 healthy subjects (matched for sex and age), to be included as control group.
Selected subjects will return for a third visit at CHUV (V3): they will start at home with an oral hydration protocol (load dose of 3 ml / kg at 8:00 am, followed by 1 ml / kg every hour between 9:00 am and 3:00 pm to avoid as much as possible changes in kidney perfusion). Patients will arrive at the Department of Nephrology and Hypertension (CHUV) at 11.00 am. In this occasion, two catheters will be placed into each patient's arm. Later, participants will be escorted to the Radiology Department to undergo four renal oxygenation imaging (between 1:00 pm and 2:00 pm) by the mean of BOLD-MRI technique. During this period, patients and control subjects will lie down and are not allowed to stand up. At T0, they will receive a bolus (0.75 ml / kg) of glucose 20%. Subsequently, four BOLD-MRI scans, together with blood tests, will be performed at T0, T1 (+10 min), T2 (+20 min), T3 (+30 min). Sodium intake will be measured by 24 hours urinary collection the day before V3 (sodium is known to influence R2*).
- Conditions
- Hyperglycemia, Glucose Intolerance
- Being tested
- glucose 20%
- Medical subject headings
- Hyperglycemia, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose 20%Other
Intravenous infusion (0.75 ml / kg) over 1 min
| Study group | Role | What they receive |
|---|---|---|
| Patient with impaired glucose tolerance | Other | Bold-MRI before and after glucose injection Receives: Other: glucose 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical and medullary renal R2* MRI signal variation, before, during and after an induced hyperglycemic state
Measured: Four R2* imaging will be performed during an investigation day between 1:00 pm and 2:00 pm
Intergroup variability of MRI R2* signal, before, during and after an induced hyperglycemic state
Measured: Four R2* imaging will be performed during an investigation day between 1:00 pm and 2:00 pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018
- Study completion31 Jan 2019
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 HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- IV administration of 0.15 g/kg of glucose in a 20% solution under standard hydration and fasting conditions
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Burnier, Centre Hospitalier Universitaire Vaudois
- Investigators
- Michel Burnier, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346149
- Sponsor's protocol ID
- SNSF132913
- Acronym
- Glucox
- Status last verified
- Jul 2019
- First submitted
- 20 Jan 2015
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pruijm M, Hofmann L, Zanchi A, Maillard M, Forni V, Muller ME, Wuerzner G, Vogt B, Stuber M, Burnier M. Blockade of the renin-angiotensin system and renal tissue oxygenation as measured with BOLD-MRI in patients with type 2 diabetes. Diabetes Res Clin Pract. 2013 Feb;99(2):136-44. doi: 10.1016/j.diabres.2012.11.004. Epub 2012 Dec 14.
PubMed 23245807
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Hyperglycemia on Renal Tissue Oxygenation as Measured By BOLD-MRI in Individuals With Impaired Glucose Tolerance and Controls
- ClinicalTrials.gov ID
- NCT02346149
- Acronym / sponsor ID
- Glucox / SNSF132913
- Conditions
- Hyperglycemia, Glucose Intolerance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 26 Jan 2015 (estimated)
- 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.
Diabetes Mellitus (DM) includes several metabolic diseases all characterized by high sugar levels in the blood. Although diabetic nephropathy is widespread, its underlying pathophysiological mechanisms remain poorly understood and, so far, little progress has been made to prevent the development of diabetic nephropathy and to delay kidney functions decline.
Increasing amount of data based on animal studies support the pathogenic role of tissue hypoxia in the development and progression of diabetic nephropathy. Blood Oxygenation-Level Dependent Magnetic Resonance Imaging (BOLD-MRI) is increasingly used in research to measure cortical and medullary oxygenation in a non-invasive manner. Interestingly, in two cross-sectional clinical studies, we have recently found a positive correlation between high circulating blood glucose levels and cortical R2* levels in type 2 DM patients. This discovery suggests that an increase in glycemia might acutely decrease renal tissue oxygenation.
The goal of this study is to investigate the impact of serum glucose on renal tissue oxygenation in healthy subjects and subjects with glucose intolerance.
Detailed description
Therefore, we plan to recruit 10 healthy subjects and 10 glucose intolerant patients with preserved kidney functions and to perform repetitive BOLD-MRI, before and after the administration of IV glucose. This will allow us to study the influence of hyperglycemia as a single factor, regardless of inflammation, oxidative stress and medical treatments, such as oral hypoglycemic agents and/or insulin, which are confounding factors present in all DM patients.
The main hypothesis of the project is that acute hyperglycemia could be partially responsible for renal tissue hypoxia detected in diabetic nephropathy cases.
In this study we will include 60 participants with a family history of diabetes, with a Body Mass Index (BMI) over 25 kg / m2 and/or having glucose intolerance. Each participant will undergo an initial glucose tolerance test. In total, we will select 10 participants with impaired glucose tolerance and 10 healthy subjects (matched for sex and age), to be included as control group.
Selected subjects will return for a third visit at CHUV (V3): they will start at home with an oral hydration protocol (load dose of 3 ml / kg at 8:00 am, followed by 1 ml / kg every hour between 9:00 am and 3:00 pm to avoid as much as possible changes in kidney perfusion). Patients will arrive at the Department of Nephrology and Hypertension (CHUV) at 11.00 am. In this occasion, two catheters will be placed into each patient's arm. Later, participants will be escorted to the Radiology Department to undergo four renal oxygenation imaging (between 1:00 pm and 2:00 pm) by the mean of BOLD-MRI technique. During this period, patients and control subjects will lie down and are not allowed to stand up. At T0, they will receive a bolus (0.75 ml / kg) of glucose 20%. Subsequently, four BOLD-MRI scans, together with blood tests, will be performed at T0, T1 (+10 min), T2 (+20 min), T3 (+30 min). Sodium intake will be measured by 24 hours urinary collection the day before V3 (sodium is known to influence R2*).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- IV administration of 0.15 g/kg of glucose in a 20% solution under standard hydration and fasting conditions
| Arm | Type | Receives |
|---|---|---|
| Patient with impaired glucose tolerance | Other | Other: glucose 20%Bold-MRI before and after glucose injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive family history of diabetes
- BMI > 25 kg / m2
- eGFR > 60 ml / min / 1.73 m2
- Understanding and signing the informed consent
Key exclusion criteria (12 listed)
- Documented cardiac disease
- Documented liver failure
- Renal malformations, kidney diseases or documented renal artery stenosis
- History of organ transplantation
- Significant comorbidities compromising life expectancy
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 |
|---|---|---|
| glucose 20%Intravenous infusion (0.75 ml / kg) over 1 min | Other | Patient with impaired glucose tolerance |
Primary outcome
Cortical and medullary renal R2* MRI signal variation, before, during and after an induced hyperglycemic state
Time frame: Four R2* imaging will be performed during an investigation day between 1:00 pm and 2:00 pm
Intergroup variability of MRI R2* signal, before, during and after an induced hyperglycemic state
Time frame: Four R2* imaging will be performed during an investigation day between 1:00 pm and 2:00 pm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Background: PubMed 23245807Pruijm M, Hofmann L, Zanchi A, Maillard M, Forni V, Muller ME, Wuerzner G, Vogt B, Stuber M, Burnier M. Blockade of the renin-angiotensin system and renal tissue oxygenation as measured with BOLD-MRI in patients with type 2 diabetes. Diabetes Res Clin Pract. 2013 Feb;99(2):136-44. doi: 10.1016/j.diabres.2012.11.004. Epub 2012 Dec 14.
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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.
Michel Burnier, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing glucose 20% in people with Hyperglycemia and Glucose Intolerance, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 31 Jul 2019. 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical and medullary renal R2* MRI signal variation, before, during and after an induced hyperglycemic state (time frame: Four R2* imaging will be performed during an investigation day between 1:00 pm and 2:00 pm). The study lists 2 primary outcomes in all. 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 NCT02346149, 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 31 Jul 2019.