Environmental Effects Type 1 Diabetes Mellitus

NCT03102476 | Completed

• 1 other identifier: Version: 3.0 (02-07-2014)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Area under the glucose infusion rate curve from 0 hours until the end of clamp.

  1 Year

• Onset of action, time from trial product administration until the blood glucose concentration has decreased at least 0.3 mmol/L (5 mg/dL) from the baseline

  I year

Secondary Outcomes (6)

• Area under the glucose infusion rate curve from 0 hours until 2 hours

  1 year

• Area under the glucose infusion rate curve from 0 hours until 4 hours

  1 year

• Area under the glucose infusion rate curve from 0 hours until 6 hours

  1 year

• Area under the glucose infusion rate curve from 4 hours until 6 hours

  1 year

• Maximum glucose infusion rate

  1 year

Study Arms (1)

Patients with Type 1 Diabetes

OTHER

Using euglycaemic clamp, the effect of different temperatures and humidity levels will be assessed on the pharmacokinetic and pharmacodynamic profiles of short-acting insulin Humalog.

Drug: Humalog

Interventions

Humalog DRUG

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

Also known as: Insulin lispro

Patients with Type 1 Diabetes

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects
• Diabetes mellitus type 1
• HbA1c ≤ 9.0 %
• Total insulin dose of \< 1.2 U/kg/day
• Age between 18 and 55 years, both inclusive
• Body mass index (BMI) between 18.0 and 28.0 kg/m2, both inclusive
• Informed consent must be obtained for all volunteers in writing

You may not qualify if:

• Known or suspected allergy to insulin.
• Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator or hospitalization for diabetic ketoacidosis during the previous 6 months.
• Clinically significant diabetic neuropathy, in particular autonomous diabetic neuropathy.
• Treatment with any other investigational drug within 3 months prior to screening. Participation in a clinical research trial in last 3 months.

Sponsors & Collaborators

• University of Hull: lead

Study Sites (1)

Hull and East Yorkshire NHS Trust

Hull, HU32RW, United Kingdom

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Thozhukat Sathyapalan, MD FRCP

  United Kingdom: Hull University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: April 5, 2017
• Study Start: June 1, 2016
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: October 31, 2018

Record last verified: 2017-03

Locations

GB (1)