NCT02157155

A Study of Intracellular Signaling in Muscle and Fat Cells During Ketosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ketoacidosis
• Diabetes Mellitus Type 1

Interventions

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

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-03-01
• Completion: 2015-09-01
• First posted: 2014-06-05
• Last updated: 2015-12-02

Locations

1 site across 1 country: Denmark