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L-carnitine PD solution for insulin sensitivity in CAPD
NCT00755456Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- Sep 2012
- Countries
- 1
- Sponsor
- Iperboreal Pharma
- Modality
- Small Molecules
- Drugs
- levocarnitine
- Conditions
- insulin resistance (IR)
01
Overview
Phase 2, randomised trial of levocarnitine in insulin resistance (IR) (2 arms), sponsored by Iperboreal Pharma. Primary endpoint: Insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp at 4 months. Started Jan 2008; status: completed.
02
Design
2 arms- Study design
- Randomized
Glucose solution
Standard PD solution with glucose
Glucose + L-carnitine
PD solution with glucose and L-carnitine
03
Who it enrols
Adult ESRD patients on CAPD for at least 3 months with stable clinical condition, excluding those with Diabetes Mellitus or recent L-carnitine use.
04
Endpoints
Primary
Insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp
Secondary
Plasma lipids and lipoprotein profile
Hemoglobin
Erythropoietin requirements
05
Results
Primary endpoints met
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