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Environmental Effects Type 1 Diabetes Mellitus

NCT03102476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-10-31

No results posted yet for this study

Summary

Type 1 Diabetes mellitus (T1D) is characterized by βcell destruction and a long life requirement of exogenous insulin. The bolus basal insulin regimen is a widely accepted therapy concept to treat hyperglycaemia in patients with T1D. This concept requires a very good knowledge of the individuals prandial and basal insulin requirements. However, insulin requirement depends on insulin absorption from the injection site and the individual's insulin sensitivity which relies on a number of effects including body composition, inflammatory processes and environmental factors. Climatic factors such as differences in air temperature could affect both, insulin absorption and insulin sensitivity as suggested by recent reports. For instance, it is reported that hot baths can accelerate the absorption of short acting but not of long acting insulin formulations from the subcutaneous depot. In addition, local warming of the injection site by a novel device (InsuPatch) results as well in an accelerated insulin action profile of short acting insulins. Moreover, Berglund et al. reported seasonal variations in insulin sensitivity in elderly men with increased insulin sensitivity during summer time.

Although an effect of temperature on insulin absorption and action can be assumed and was subject to current clinical trials, there is only little knowledge on the effect of humidity and the cumulative effect of humidity and temperature on insulin pharmacodynamics and pharmacokinetics. For subjects with type 2 diabetes it was reported that accommodation to high temperatures and moist air of more than 75% is impaired compared to healthy subjects as determined by skin blood flow, temperature and moisture. Although it can be estimated that changes in blood flow due to hot and moist air affect the pharmacokinetics and pharmacodynamics of subcutaneous prandial insulins, to our knowledge no such study in subjects with T1D using the euglycaemic clamp technique was carried out yet. In order to assess the effect of temperature and humidity on insulin action, subjects with type 1 diabetes will be administered a single dose of short acting insulin in an environmental chamber either at 15°C or a warm environment of 40°C with either a low or high humidity (10% vs. 90%). Moreover, an exploratory part of the trial will evaluate the measurement performance of several blood glucose meters under the experimental climatic situations.

Conditions

  • Type1diabetes

Interventions

DRUG

Humalog

Subcutaneous injection of Humalog and assessing Pharmacokinetics and Pharmacodynamics properties of Humalog under different environmental conditions

Sponsors & Collaborators

  • University of Hull

    lead OTHER

Principal Investigators

  • Thozhukat Sathyapalan, MD FRCP · United Kingdom: Hull University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-02-02
Completion
2018-02-02

Countries

  • United Kingdom

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 NCT03102476 on ClinicalTrials.gov