- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398995
Managing Insulin Pumps for Exercise (Study 2)
To Consider the Effect of the Timing of a Reduction in Basal Insulin Infusion Rate to 50% of Normal Prior to Exercise on Glycaemic Control in People With Type 1 Diabetes Treated With CSII
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants recruited will have type 1 diabetes treated with CSII. Each participant will be required to attend on 5 separate occasions. The first visit can take place at any time of day. At this first visit formal, written consent will be obtained for participation in the trial. Following this an assessment will be made of VO2 MAX(maximal oxygen uptake during exercise) using the Balke-Ware treadmill protocol. Once this is finished the first visit will be completed.
The other 4 visits will all take place 2 hours following a lunch containing 60 grams of carbohydrate. Advice will be given about how this can be achieved. On arrival a cannula will be inserted in the dorsum of a hand and blood samples taken. The hand will be armed to allow the taking of arterialised blood samples. Further blood samples will be taken after 30, 60 and 90 minutes and then exercise will commence. Participants will be asked to reduce their basal insulin infusion rate to 50% of usual either immediately after the cannula has been inserted or 30 minutes later (1 hour prior to exercise), 60 minutes later (30 minutes prior to exercise) or 90 minutes later (at the start of exercise). These four conditions will be presented to each participant in a randomised order. Participants will exercise for 60 minutes at 50% VO2 MAX on an electronically braked cycle ergometer. At the end of exercise a set of blood samples will be taken. Participants will then rest for 30 minutes and a final set of blood samples will be taken. After this the cannula will be removed and the study visit will be complete. A snack will be offered.
In the event of hypoglycaemia identified on point of care testing a blood sample will be taken for laboratory confirmation. Participants will be given 15 grams of carbohydrate but permitted to continue exercising unless they feel that the exercise has become significantly more difficult, they feel unwell or the investigator has any concerns. Participants will be given 15 grams of rapid acting carbohydrate, repeated every 10-15 minutes until blood glucose levels rise above 4mmol/l.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Buckinghamshire
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High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
- Wycombe Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged between 18 and 65 years
- Diagnosed with Type 1 diabetes mellitus
- Treated with CSII for at least 3 months
- Exercises regularly for more than 1 hour per week
Exclusion Criteria:
People with any one of the following complications of diabetes:
- stage 2+ diabetic retinopathy
- renal impairment (with creatinine >150micromol/l)
- known history or symptoms of cardiovascular disease
- foot ulceration
- peripheral vascular disease
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Known hypoglycaemia unawareness
- Treatment with drugs known to interfere with glucose metabolism
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 90 minutes
Basal insulin infusion reduced to 50% of normal 90 minutes prior to exercise
|
Each participant in this cross-over trial will participate in the 4 arms of the trial.
They will be presented with the four conditions in randomised order - reducing their basal insulin infusion rate to 50% of normal at the four time points specified.
A comparison will be made between the conditions.
|
Experimental: 60 minutes
Basal insulin infusion reduced to 50% of normal 60 minutes prior to exercise
|
Each participant in this cross-over trial will participate in the 4 arms of the trial.
They will be presented with the four conditions in randomised order - reducing their basal insulin infusion rate to 50% of normal at the four time points specified.
A comparison will be made between the conditions.
|
Experimental: 30 minutes
Basal insulin infusion reduced to normal 30 minutes prior to exercise
|
Each participant in this cross-over trial will participate in the 4 arms of the trial.
They will be presented with the four conditions in randomised order - reducing their basal insulin infusion rate to 50% of normal at the four time points specified.
A comparison will be made between the conditions.
|
Experimental: Start
Basal insulin infusion reduced to 50% of normal at the start of exercise
|
Each participant in this cross-over trial will participate in the 4 arms of the trial.
They will be presented with the four conditions in randomised order - reducing their basal insulin infusion rate to 50% of normal at the four time points specified.
A comparison will be made between the conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of glucose excursion (change in blood glucose) between baseline and the end of exercise between the four conditions.
Time Frame: Samples taken on arrival and at the end of exercise
|
Samples taken on arrival and at the end of exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison between the four conditions of change in blood glucose levels between baseline and the beginning of exercise, and between the beginning and end of exercise.
Time Frame: Samples taken at baseline, beginning and end of exercise
|
Samples taken at baseline, beginning and end of exercise
|
|
Levels of NEFA and lactate will be compared between the four conditions
Time Frame: Samples will be taken at the 6 time points detailed below
|
Samples will be taken in each condition at baseline (90 minutes prior to exercise), after 30 minutes (60 minutes prior to exercise), after 60 minutes (30 minutes prior to exercise), after 90 minutes (at the start of exercise), after 150 minutes (at the end of 1 hour of exercise) and at 180 minutes (30 minutes after the end of exercise)
|
Samples will be taken at the 6 time points detailed below
|
Correlation between levels of NEFA and lactate and blood glucose will be considered.
Time Frame: Samples will be taken at the time points detailed below
|
Samples will be taken in each condition at baseline (90 minutes prior to exercise), after 30 minutes (60 minutes prior to exercise), after 60 minutes (30 minutes prior to exercise), after 90 minutes (at the start of exercise), after 150 minutes (at the end of 1 hour of exercise) and at 180 minutes (30 minutes after the end of exercise)
|
Samples will be taken at the time points detailed below
|
Ratio of respiratory quotient (RQ) at the beginning of exercise to RQ at the end of exercise compared between the four conditions.
Time Frame: Breath by breath data will be recorded for 2 minutes at the start and the end of the exercise period
|
Breath by breath data will be recorded for 2 minutes at the start and the end of the exercise period
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ian W Gallen, MD FRCP, Buckinghamshire Healthcare NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RXQ404
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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