Environmental effects T1DM
Research type
Research Study
Full title
A study to assess environmental effects of temperature and humidity on pharmacokinetics and pharmacodynamics of a prandial insulin in subjects with type 1 diabetes
IRAS ID
161401
Contact name
Thozhukat Sathyapalan
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
Research summary
In type 1 Diabetes mellitus (T1DM), the pancreas (a small gland behind the stomach) does not produce the insulin hormone that usually helps keep blood glucose at normal levels. Patients with T1DM therefore require injections of insulin so that their blood glucose levels do not go dangerously high. The amount of insulin that needs to be injected can vary from person to person and the dose needed can even vary from day-to-day for the same individual. There are two main reasons that the insulin dose needs to be different between patients. One is that the speed the insulin is absorbed from where it is injected can be different from person to person. The second is the individual’s insulin sensitivity (or how well the insulin ‘works’ to lower blood glucose) relies on a number of factors including body weight and environmental factors.
Environmental factors such as differences in air temperature have been shown to affect both insulin absorption and insulin sensitivity, even in the same person. For instance, it has been reported that hot baths or warming of the skin where the insulin is injected can speed up the absorption of insulin. Also insulin sensitivity has been found out to be increased during summer time meaning less insulin is needed to lower blood glucose.
From these and other studies, we have some knowledge of the effect that changes in air temperature can have on how quickly insulin is absorbed and how well it can work once it is absorbed. However, the effect on patients with type 1 diabetes is not known and neither is the effect of humidity or the combined effect of humidity and temperature.
In order to assess the effects of temperature and humidity on the speed insulin is absorbed and how well it works, subjects with type 1 diabetes will be given a single dose of short acting insulin either at 15°C or a warm environment of 30°C that is either at low (10%) or high (60%) humidity.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1129
Date of REC Opinion
5 Feb 2015
REC opinion
Further Information Favourable Opinion