Managing Insulin Pumps for Exercise - Study 1
A Comparison of Metabolism During Moderate Exercise Between Healthy Volunteers and People With T1DM Treated With CSII Using 70% of Their Usual Insulin Basal Rate
1 other identifier
observational
16
1 country
1
Brief Summary
People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous insulin infusion (CSII) therapy, in which a background or basal level of insulin is constantly infused under the skin by a special pump, with bolus doses of insulin given to accompany food. Clinical experience suggests that this may be particularly useful for managing diabetes for exercise, but there is limited experimental evidence to support this. The aim of this research , which is divided into three parts, is to investigate the hypothesis that the physiological response to sub-maximal (moderate) exercise of a person with type 1 diabetes treated with CSII, can be made to approximate more closely to the physiological response of a healthy individual by a prior reduction of their basal insulin infusion rate. This first part of the research is designed to compare metabolic response to exercise between people without diabetes and people with T1DM running there insulin pump at the usual basal rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 20, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 8, 2011
November 1, 2011
7 months
July 20, 2011
November 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose excursion
The primary outcome measure is change in blood glucose (glucose excursion) between the start and the end of exercise
Glucose will be measured at the start and end of 1 hour of exercise at 50% VO2 MAX during the second study visit
Secondary Outcomes (10)
Comparison between the two groups of levels of lactate
Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Multiple correlation between blood glucose values and values of lactate, NEFA, betahydroxybutyrate, catecholamines, glucagon, insulin, C-peptide, human growth hormone and cortisol
Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Ratio of respiratory quotient (RQ) at the beginning of exercise to RQ at the end of exercise, compared between the two groups, which will give information about fuel use during exercise.
Respiratory quotient will be calculated using a breath by breath analyser using 2 minutes of data from the start at the end of exercise
Comparison between the two groups of levels of non-esterified fatty acids (NEFA)
Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
Comparison between the two groups of levels of beta-hydroxybutyrate
Samples will be obtained on arrival, 30 minutes later (at the start of exercise), at the end of exercise (1 hour later) and at the end of the study visit (30 minutes later)
- +5 more secondary outcomes
Study Arms (2)
Type 1 Diabetes
Participants with type 1 Diabetes running their insulin pump at 70% of usual basal rate
Participants without diabetes
Participants without diabetes or evidence of impaired glucose regulation
Eligibility Criteria
Participants with Type 1 Diabetes treated with insulin pump therapy who exercise for at least 1 hour each week and comparable participants without diabetes mellitus
You may qualify if:
- For participants with Type 1 Diabetes Mellitus
- 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
- For participants without Type 1 Diabetes Mellitus
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged between 18 and 65 years
- Exercises regularly for more than 1 hour per week
You may not qualify if:
- For participants with type 1 Diabetes Mellitus
- 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
- For participants without Type 1 Diabetes Mellitus
- Known pregnancy or breastfeeding
- Untreated or unstable respiratory disease
- Diagnosis of impaired fasting glucose, impaired glucose tolerance or diabetes mellitus
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Buckinghamshire Healthcare NHS Trustlead
- Animas Corporationcollaborator
Study Sites (1)
Wycombe Hospital
High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom
Biospecimen
All samples retained will be plasma samples. Any samples remaining after analysis will be retained until the 3 trials in this research study have been completed, and will then be destroyed.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian W Gallen, MD FRCP
Buckinghamshire Healthcare NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2011
First Posted
July 25, 2011
Study Start
January 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 8, 2011
Record last verified: 2011-11