lipodystrophy patients, patients after liver transplantation and healthy controls
Conditions
Interventions
Trade Name: Myalept
Product Name: Myalept
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: metrelpetin
Current Sponsor code: Thalamus_V2
Other descriptive n
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: + Age between 18 – 70 years + Plasma trigylcerides = 700 mg/dl (aim 2 and 3 – lipodystrophic/LTX cohort; Healthy human subject cohort: 6 months after LTX Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: + overt diabetes mellitus (HbA1c = 6.5%); except for lipodystrophy patients (aim 3) + history of recent acute pancreatitis ( 700mg/dl + severe liver disease (LFTs 3x ULN) + pregnancy + T-Cell Lymphoma + Autoimmune disease + consummation of alcoholic beverages during the last 48 hours + history of polyneuropathy or gastropareses (including regular use of gabapentin and/or metoclopramide or other common drugs to treat gastropareses or neuropathy) + body-Mass-Index > 35 kg/m² + tendency towards claustrophobia + simultaneous participation in another active clinical study + allergies against soy products, eggs, peanuts (in case intralipid is infused) + glomerular filtration rate < 65 mL/min/1.73 m2 (calculated with the MDRD formula) + healthy subjects with a hepatic lipid content = 10 % water signal are excluded + metal devices or other magnetic material in or on the subjects body which will be hazardous for NMR investigation [heart pacemaker, coronary stents and heart valves (in case these devices are not compatible with a 7T MT), brain (aneurysm) clip, nerve stimulators, electrodes, ear implants, penile implants, colored contact lenses, patch to deliver medications through the skin, coiled spring intrauterine device, vascular filter for blood clots, orthodontic braces, shunt-spinal or ventricular, any metal implants (rods, joints, plates, pins, screws, nails, or clips), embolization coil, or any metal fragments or shrapnel in the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Define the role of leptin action in regulating hepatic VLDL secretion, lipid content and energy metabolism in healthy human subjects;Secondary Objective: Assess leptin action in denervated livers. Assess the effects of leptin in patients with lipodystrophy. ;Primary end point(s): •Leptin induced changes in VLDL secretion •Impact of vagal stimulation on VLDL secretion ;Timepoint(s) of evaluation of this end point: at baseline and 180 minutes after s.c. injection of metreleptin or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in hepatic lipid content • Changes in metabolism of energy rich phosphates (ATP turnover) • Impact of hepatic denervation on VLDL secretion ;Timepoint(s) of evaluation of this end point: at baseline and 180 minutes after s.c. injection of metreleptin or placebo | — |
Countries
Austria
Contacts
Public ContactSekretariat Endokrinologie
Medical University of Vienna
Outcome results
None listed