Effect of Acute Hyperglycemia on Renal Tissue Oxygenation

NCT02346149 | Completed Early Phase 1

• 1 other identifier: SNSF132913
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia; Glucose Intolerance

Outcome Measures

Primary Outcomes (2)

• Cortical and medullary renal R2* MRI signal variation, before, during and after an induced hyperglycemic state

  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

  Four R2* imaging will be performed during an investigation day between 1:00 pm and 2:00 pm

Study Arms (1)

Patient with impaired glucose tolerance

OTHER

Bold-MRI before and after glucose injection

Other: glucose 20%

Interventions

glucose 20% OTHER

Intravenous infusion (0.75 ml / kg) over 1 min

Patient with impaired glucose tolerance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Department of Nephrology, Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 23245807 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Glucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michel Burnier, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: IV administration of 0.15 g/kg of glucose in a 20% solution under standard hydration and fasting conditions

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 26, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: January 31, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

CH (1)