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

University of Aarhus

Status: Completed

Conditions: Diabetes Mellitus Type 1; Ketoacidosis

Treatments: Biological: LPS

Study type: Interventional

Funder types: Other

Identifiers

NCT02157155

1-10-72-98-14

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes type 1
• 19 < BMI < 26
• minimal or negative C-peptide
• written consent

Exclusion criteria

• Severe comorbidity
• regular medication apart from insulin

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Intervention

Experimental group

Description:

Insulin reduction and mimic infection with LPS

Treatment:

Biological: LPS

Control

No Intervention group

Description:

Normal insulin and no LPS