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

NCT02157155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2015-12-02

No results posted yet for this study

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

BIOLOGICAL

LPS

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Mads Svart, MD · Aarhus University / Aarhus University Hospital

  • Niels Møller, MD · Aarhus University / Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-03-31
Completion
2015-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157155 on ClinicalTrials.gov