NCT01327378|Completed
The Incretin Effect in Patients With Kidney Impairment
UREMINC
The Incretin Effect in Non-diabetic Patients With Severe Renal Impairment Depending on Chronic Dialysis Treatment
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UREMINC
The Incretin Effect in Non-diabetic Patients With Severe Renal Impairment Depending on Chronic Dialysis Treatment
Sponsor study identifier
observational
30
1 country
1
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)The current study explores the incretin effect; a central mechanism of sugar metabolism. People with type 2 diabetes have a markedly reduced incretin effect, while the incretin effect never has been studied in patients with severe chronic renal failure. Non-diabetic patients with severe kidney failure and patients with diabetes and normal kidney function share several pathophysiological traits, including decreased sensitivity to insulin, fasting hyperinsulinaemia and impaired beta cell function. The investigators expect the incretin effect to be affected in patients with chronic renal failure without diabetes, which in time can result in therapeutic changes in this group of patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 2010
Actual (reported)October 2010
Actual (reported)March 29, 2011
Actual (reported)April 1, 2011
Actual (reported)Incretin effect
IE= 100%\*(iAUC,OGTT - iAUC,IIGI)/iAUC,OGTT Assessed at two separate examination days. Day 1: Oral glucose tolerance test (OGTT), Day 2: Intravenous isoglycaemic glucose infusion (IIGI). Data will be presented when all analyses have been performed. Estimated in May 2011.
Minimum 3 days and maximum 3 weeks between the two examination days. Cross-sectional design. No follow up.
Gastric-induced glucose disposal (GIGD)
Minimum 3 days and maximum 3 weeks between the two examination days. Cross-sectional design. No follow up.
Chronic dialysis treatment, N=10 OGTT,120 min \< 7.8 mmol/L
Chronic dialysis treatment, N=10 OGTT,120 min 7.7\<11.1 mmol/L
Healthy Control subjects, N=10 OGTT,120 min \<7.8 mmol/L
3 groups 1. Chronic hemodialysis treatment. Normal glucose tolerance (NGT). N=10 2. Chronic hemodialysis treatment. Impaired glucose tolerance (IGT). N=10 3. Healthy control subjects. Normal glucose tolerance. N=10 Glucose tolerance is evaluated at the screeningday. A 75 gram oral glucose tolerance test (OGTT) is performed and the 120 minute value sets the glucose tolerance. NGT: \< 7.8 mmol/L, IGT: \> 7.7 mmol/L and \< 11.1 mmol/L (according to WHO guidelines).
Department of Nephrology P 2131, Rigshospitalet
Copenhagen Ø, 2100, Denmark
Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.
Idorn T, Knop FK, Jorgensen M, Holst JJ, Hornum M, Feldt-Rasmussen B. Gastrointestinal factors contribute to glucometabolic disturbances in nondiabetic patients with end-stage renal disease. Kidney Int. 2013 May;83(5):915-23. doi: 10.1038/ki.2012.460. Epub 2013 Jan 16.
Plasma (10 ml per participant)
Bo Feldt-Rasmussen, Prof, DMSc
Department of Nephrology, Rigshospitalet, University of Copenhagen, Denmark
30 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2011
First Posted
April 1, 2011
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency
Underlying Causes of Low Vitamin K Status in Hemodialysis Patients
Contact the study team to confirm eligibility.
Primary Completion
October 2010
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
April 1, 2011
Record last verified: 2010-06
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Source: ClinicalTrials.gov.
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