eptin in hepatic lipid metabolism in humans

Phase 1

• Conditions: lipodystrophy patients, patients after liver transplantation and healthy controls; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003014-22-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-29
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

+ Age between 18 – 70 years
+ Plasma trigylcerides = 700 mg/dl (aim 2 and 3 – lipodystrophic/LTX cohort; Healthy human subject cohort: < 150 mg/dl
+ male sex (healthy human subject cohort); female patients are eligible in LTX/lipodystrophic cohort
+ patients with generalized or partial lipodystrophy (based on clinical/genetic diagnosis): drug-naive patients will be preferentially recruited in case an N of 4-5 cannot be met, patients off-treatment are also recruited; no metreleptin treatment 2-3 weeks prior to the study (note that metreleptin treatment will be tapered before discontinuation to avoid triglyceride rebound in case patients are on metreleptin
+ LTX cohort: no major change (i.e. drug-class switch; dose adjustments are allowed) in immunosuppressive therapy regime in the last 4 weeks; > 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

+ overt diabetes mellitus (HbA1c = 6.5%); except for lipodystrophy patients (aim 3)
+ history of recent acute pancreatitis (< 6 months)
+ serum TGs > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified