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Effect of Acute Hyperglycemia on Renal Tissue Oxygenation (Glucox)

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ClinicalTrials.gov Identifier: NCT02346149
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Michel Burnier, Centre Hospitalier Universitaire Vaudois

Brief 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 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.


Condition or disease Intervention/treatment Phase
Hyperglycemia Glucose Intolerance Other: glucose 20% Early Phase 1

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*).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Effect of Acute Hyperglycemia on Renal Tissue Oxygenation as Measured By BOLD-MRI in Individuals With Impaired Glucose Tolerance and Controls
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
Drug Information available for: Dextrose

Arm Intervention/treatment
Patient with impaired glucose tolerance
Bold-MRI before and after glucose injection
Other: glucose 20%
Intravenous infusion (0.75 ml / kg) over 1 min




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive family history of diabetes
  • BMI > 25 kg / m2
  • eGFR > 60 ml / min / 1.73 m2
  • Understanding and signing the informed consent

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346149


Locations
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Switzerland
Department of Nephrology, Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Michel Burnier, MD Centre Hospitalier Universitaire Vaudois

Publications:
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Responsible Party: Michel Burnier, Professor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02346149     History of Changes
Other Study ID Numbers: SNSF132913
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases