Clinical trial NCT02204839: Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM
Official title: The Metabolic and Glycaemic Effects of a Combined Basal-Bolus Insulin Reduction And Carbohydrate Feeding Strategy For Evening Exercise in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: T1DM, Exercise, Hypoglycaemia
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Newcastle University
First posted: 2014-07-30
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate feeding and rapid-acting insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-50 years old (male or female).
* Free from any diabetes related complications (apart from mild background diabetic retinopathy).
* HbA1c \<8.5%.
* Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
* Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

* Aged younger than 18, or older than 50 years.
* Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
* HbA1c \>8.5%.
* Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
* Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Primary outcomes:
measure: 24 hour blood glucose area under the curve
timeFrame: 24 hours
Secondary outcomes:
measure: Ketonaemia
timeFrame: 60 minutes before and 24 hours post-exercise
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Clinical Research Facility, Royal Victoria Infirmary
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Daniel J West, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campbell MD, West DJ, O'Mahoney LL, Pearson S, Kietsiriroje N, Holmes M, Ajjan RA. The relative contribution of diurnal and nocturnal glucose exposures to HbA1c in type 1 diabetes males: a pooled analysis. J Diabetes Metab Disord. 2022 Mar 31;21(1):573-581. doi: 10.1007/s40200-022-01015-1. eCollection 2022 Jun.
citation: Campbell MD, Walker M, Bracken RM, Turner D, Stevenson EJ, Gonzalez JT, Shaw JA, West DJ. Insulin therapy and dietary adjustments to normalize glycemia and prevent nocturnal hypoglycemia after evening exercise in type 1 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2015 May 12;3(1):e000085. doi: 10.1136/bmjdrc-2015-000085. eCollection 2015.