CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Insulin withdrawal +1 moredrug
Likely dose
Norditropin 0,4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02077348
NCT02077348N/ACompleted

Metabolic Signalling in Muscle- and Adipose Tissue Following Insulin Withdrawal and Growth Hormone Injection in Type I Diabetes Mellitus, a Clinical Experimental Study.

University of Aarhus·interventional·Posted Mar 4, 2014·Updated Feb 24, 2016

In Brief

A clinical study evaluating Insulin withdrawal and Norditropin for Diabetes Mellitus Type I and Ketoacidosis. Completed, enrolled 9 participants across 1 site.

Detailed Summary

Diabetes mellitus type I (DM I) is characterized by lack of endogenous insulin and these patients are 100% dependent on insulin substitution to survive. Insulin is a potent anabolic hormone with its primary targets in the liver, the skeletal muscle-tissue and - adipose-tissue. Severe lack of insulin leads to elevated blood glucose levels, dehydration, electrolyte derangement, ketosis and thus eventually ketoacidosis. Insulin signalling pathways are well-known. Growth hormone (GH) is also a potent anabolic hormone, responsible for human growth and preservation of protein during fasting. GH (in concert with lack of insulin) induces lipolysis during fasting. It is not known how GH exerts its lipolytic actions. The aim is to define insulin and growth hormone (GH) signalling pathways in 3 different states in patients with DM I. And to test whether ATGL-related lipolysis in adipose tissue contributes to the development of ketosis. 1. Good glycemic control 2. Lack of insulin (ketosis/ketoacidosis) 3. Good glycemic control and GH injection

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 4, 2014
Enrollment StartMay 1, 2014
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.3 years ago

Interventions

Insulin withdrawaldrug

Withdrawal of usual (evening) insulin, replaced by Insuman Rapid (10% of the amount of usual evening insulin) as a continuous IV- administration overnight until 8 o'clock on the study day.

Norditropindrug

0,4 mg of GH administered at 7.05 A.M. on the study day.