Role of Magnetic Resonance Imaging (MRI) in evaluating the impact of Empagliflozin on kidneys in patients with Type 2 diabetes.

Phase 4

Recruiting

• Conditions: Type 2 Diabetes Mellitus; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12619000933156
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-04
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Part 1: Healthy volunteers:
-Able to provide informed written consent
-Greater than or equal to 18 years old and less than or equal to 75 years old.

Part 2: Patients with Type 2 diabetes
- Able to provide informed written consent
- Patients greater than or equal to 18 years old and less than or equal to 75 years old, on existing diabetes treatments other than GLP1 agonists
- Patients with T2DM with normal and impaired renal function (age adjusted measured GFR of greater than or equal to 45 ml/min/1.73m²)
- Mild hyperglycaemia (HbA1c=7.0-9.0%). For patients already on sulfonylurea or insulin management of diabetes, only patients with HbA1c between 7-9.0% will be eligible, to minimise risk of hypoglycaemia.
-Patients who meet the above inclusion criteria, on existing SGLT2 inhibitors or DPP4 inhibitors, will be eligible to participate following 2 week washout of these medications.

Exclusion Criteria

Part 1: Healthy volunteers:
-Volunteers who are unable to provide informed consent
-Any prior history of renal disease, cardiovascular disease or diabetes
-Contraindications to MRI (e.g.: pacemaker) as identified in the MRI safety questionnaire and via repeated verbal screening at recruitment and prior to each study visit.
-Pregnant or breast feeding
-Claustrophobia
-Inability to lie still for 90 minutes
-Allergy to gadolinium-based contrast agents
-eGFR<90 ml/min/1.73m²

Part 2: Patients with Type 2 diabetes:
- Patients who are unable to provide informed consent
- Contra-indication or allergy to gadolinium based or iodine-based contrast agent
- eGFR outside specified range
- Uncontrolled hyperglycaemia, specified as overnight fasting blood glucose greater than 13.3 mmol/L
- History of Pancreatitis
- Contraindications to MRI (e.g.: pacemaker etc) as defined in the MRI safety questionnaire
- Pregnant or breast feeding
- Claustrophobia
- Inability to lie still for 1 hour
- Active drug or heavy alcohol use
- Active malignancy
- Use of warfarin, opioids, corticosteroids
- Excluded because of unacceptable adverse events from study treatment
- Haemoglobin less than 130 g/L – to remove potential confounding effect of anaemia on BOLD derived metrics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure for the clinical trial will be change in baseline MRI-derived Glomerular Filtration Rate (GFR) compared to MRI-derived Glomerular Filtration Rate (GFR) following 12-14 weeks empagliflozin to post-treatment. [Baseline visit and post treatment visit (Week 12) for each of empagliflozin and sitagliptin. ]