CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
LPSbiological
Likely dose
Not stated in record
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Search/NCT02157155
NCT02157155N/ACompleted

The Role of ATGL and G0/G1 Switch Gene Complex in Lipopolysaccaride (LPS) Induced Ketosis - a Controlled, Randomised, Clinical Experimental Study

University of Aarhus·interventional·Posted Jun 5, 2014·Updated Dec 2, 2015

In Brief

A clinical study evaluating LPS for Ketoacidosis and Diabetes Mellitus Type 1. Completed, enrolled 9 participants across 1 site.

Detailed Summary

Hypothesis 1. To define whether stimulation of ATGL and suppression of G0/G1 switch gene occur in the initial phases of diabetic ketoacidosis and thus can be identified as the primary mechanisms behind this life threatening condition. 2. Make a human model for studying ketoacidosis. The investigators plan to reduce in their regular insulin over night. In the morning we administer endotoxin, which together with a relative lack of insulin will initiate ketogenesis - a state of ketoacidosis. On another occasion strict glycemic control is imposed by means of intravenous insulin. The testing is done two separate days with at least 3 weeks in between and patients are admitted to hospital the evening before the day of testing. The investigators use isotopic tracers to determine metabolic fluxes and analyse fat (ATGL, G0/G1 switch gene) and muscle biopsies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 5, 2014
Enrollment StartJun 1, 2014
Primary CompletionMar 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.1 years ago

Interventions

LPSbiological

LPS is endotoxin from gram negative bacteria. It is used scientifically to mimic infection lasting 4-8 hours.