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Environmental Effects Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03102476
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):
Thozhukat Sathyapalan, University of Hull

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.

Condition or disease Intervention/treatment
Type1diabetes Drug: Humalog

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Assess Environmental Effects of Temperature and Humidity on Pharmacokinetics and Pharmacodynamics of Prandial Insulin in Subjects With Type 1 Diabetes
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Patients with Type 1 Diabetes
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
Subcutaneous injection of Humalog and assessing Pharmacokinetics and Pharmacodynamics properties of Humalog under different environmental conditions
Other Name: Insulin lispro

Primary Outcome Measures :
  1. Area under the glucose infusion rate curve from 0 hours until the end of clamp. [ Time Frame: 1 Year ]
  2. 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 [ Time Frame: I year ]

Secondary Outcome Measures :
  1. Area under the glucose infusion rate curve from 0 hours until 2 hours [ Time Frame: 1 year ]
  2. Area under the glucose infusion rate curve from 0 hours until 4 hours [ Time Frame: 1 year ]
  3. Area under the glucose infusion rate curve from 0 hours until 6 hours [ Time Frame: 1 year ]
  4. Area under the glucose infusion rate curve from 4 hours until 6 hours [ Time Frame: 1 year ]
  5. Maximum glucose infusion rate [ Time Frame: 1 year ]
  6. Time to maximum glucose infusion rate curve [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial) and/or resting supine heart rate outside the range 50 -90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives.
  • Treatment with any other investigational drug within 3 months prior to screening. Participation in a clinical research trial in last 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102476

Contact: Thozhukat Sathyapalan, MD, FRCP 01482675312 thozhukat.sathyapalan@hyms.ac.uk
Contact: Ahmed Al-Qaissi, MRCP 01482 675364 a.al-qaissi@hull.ac.uk

United Kingdom
Hull and East Yorkshire NHS Trust Recruiting
Hull, United Kingdom, HU32RW
Contact: Thozhukat Sathyapalan, MD FRCP    01482675312    thozhukat.sathyapalan@hyms.ac.uk   
Contact: Ahmed Al-Qaissi, MRCP    01482675314    a.al-qaissi@hull.ac.uk   
Sponsors and Collaborators
University of Hull
Principal Investigator: Thozhukat Sathyapalan, MD FRCP United Kingdom: Hull University

Responsible Party: Thozhukat Sathyapalan, Professor, University of Hull
ClinicalTrials.gov Identifier: NCT03102476     History of Changes
Other Study ID Numbers: Version: 3.0 (02-07-2014)
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs