Effects of Liraglutide on Kidney Function in Type 2 Diabetic Patients
Recent studies in rodents show that glucagon-like peptide-1 (GLP-1) analogues protect against diabetic nephropathy. We hypothesise that this is also the case in humans. This study will investigate the short-term effect of liraglutide (GLP-1 analogue) on the kidneys in type 2 diabetic patients. Impact on basic kidney physiological will be determined and kidney injury markers will be measured as surrogate parameters of kidney protection.
Type 2 Diabetes Mellitus
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-blinded, Cross-over Study Investigating the Short-term Impact of Liraglutide on Kidney Function in Diabetic Patients|
- Glomerular Filtration Rate (51Cr-EDTA plasma clearance) [ Time Frame: 10-15 hours post-dose ] [ Designated as safety issue: No ]
- Renal Blood Flow (functional magnetic resonance imaging) [ Time Frame: 15 hours post-dose ] [ Designated as safety issue: No ]
- Renal electrolyte clearance [ Time Frame: 10-15 hours post-dose ] [ Designated as safety issue: No ]Sodium, potassium, calcium, lithium and osmotically actice substances.
- Excretion of kidney injury markers [ Time Frame: 0-10 hours and 10-15 hours post-dose ] [ Designated as safety issue: No ]Albumin, NGAL, KIM-1, angiotensinogen and 8-OHdG.
- Plasma concentrations of various hormones [ Time Frame: 10-15 hours post-dose ] [ Designated as safety issue: No ]Angiotensin II, renin, aldosterone, atrial natriuretic peptide, catecholamines.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
1.2 mg liraglutide sc. (single-dose)
Other Name: Victoza
Placebo Comparator: Placebo-liraglutide
Placebo liraglutide sc. (single-dose)
Other Name: Isotonic saline
|Contact: Jeppe Skov, MD||78462071 ext +firstname.lastname@example.org|
|Aarhus University Hospital, Department of Endocrinology and Diabetes||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Jeppe Skov, MD 78462071 ext +45 email@example.com|
|Principal Investigator: Jeppe Skov, MD|
|Principal Investigator:||Jens S Christiansen, Professor||Aarhus University Hospital, Department of Endocrinology and Diabetes|