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Managing Insulin Pumps for Exercise - Study 1

This study has been completed.
Sponsor:
Collaborator:
Animas Corporation
Information provided by (Responsible Party):
Buckinghamshire Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01401127
First received: July 20, 2011
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Type 1 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Buckinghamshire Healthcare NHS Trust:

Primary Outcome Measures:
  • Glucose excursion [ Time Frame: Glucose will be measured at the start and end of 1 hour of exercise at 50% VO2 MAX during the second study visit ] [ Designated as safety issue: No ]
    The primary outcome measure is change in blood glucose (glucose excursion) between the start and the end of exercise


Secondary Outcome Measures:
  • Comparison between the two groups of levels of lactate [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Multiple correlation between blood glucose values and values of lactate, NEFA, betahydroxybutyrate, catecholamines, glucagon, insulin, C-peptide, human growth hormone and cortisol [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Respiratory quotient will be calculated using a breath by breath analyser using 2 minutes of data from the start at the end of exercise ] [ Designated as safety issue: No ]
  • Comparison between the two groups of levels of non-esterified fatty acids (NEFA) [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Comparison between the two groups of levels of beta-hydroxybutyrate [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Comparison between the two groups of levels of circulating catecholamines [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Comparison between the two groups of levels of glucagon [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Comparison between the two groups of levels of circulating insulin [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Comparison between the two groups of levels of human growth hormone [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Comparison between the two groups of levels of cortisol [ Time Frame: 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) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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.


Estimated Enrollment: 16
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

For the first part of the study, participants will be either people with type 1 diabetes treated with insulin pump therapy or volunteers without diabetes. The 2 groups will be matched as far as possible by age, body mass index and usual level of activity. Participants will attend an exercise laboratory on 2 occasions. On the first occasion, which can take place at any time of day, formal written consent will be obtained for participation in the study. Participants will then undergo measurement of maximal exercise capacity (VO2 MAX). On the second occasion they will attend 2 hours after a lunch containing 60 grams of carbohydrate (advice will be given on how this can be achieved). A cannula will be inserted on arrival and blood samples obtained. Arterialised samples will be obtained by using a heated hand technique. Once the cannula has been inserted participants with type 1 diabetes will be asked to reduce the basal insulin infusion rate on their insulin pump to 70% of normal until the end of the study visit. After 30 minutes a further set of blood samples will be obtained, and participants will then start to exercise for 1 hour at 50% VO2 MAX. A further set of blood samples will be obtained at the end of the hour of exercise. Participants will then rest for 30 minutes before a final set of blood samples is taken. At this point the cannula will be removed and the study visit ends. Participants with diabetes will be given the choice to return basal insulin infusion rate to normal at this point. A snack will be offered.

Blood glucose will be monitored every 10 minutes and also if a participant feels symptoms of hypoglycaemia. If hypoglycaemia occurs the protocol will be stopped and carbohydrate given until the blood glucose level returns to the normal range.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

For participants with type 1 Diabetes Mellitus

  • People with any one of the following complications of diabetes:

    1. stage 2+ diabetic retinopathy
    2. renal impairment (with creatinine >150micromol/l)
    3. known history or symptoms of cardiovascular disease
    4. foot ulceration
    5. 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
  • Treatment with drugs known to interfere with glucose metabolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401127

Locations
United Kingdom
Wycombe Hospital
High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
Sponsors and Collaborators
Buckinghamshire Healthcare NHS Trust
Animas Corporation
Investigators
Principal Investigator: Ian W Gallen, MD FRCP Buckinghamshire Healthcare NHS Trust
  More Information

No publications provided

Responsible Party: Buckinghamshire Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01401127     History of Changes
Other Study ID Numbers: RXQ404(1)
Study First Received: July 20, 2011
Last Updated: November 7, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Buckinghamshire Healthcare NHS Trust:
Type 1 Diabetes Mellitus
Exercise
Continuous Subcutaneous Insulin Infusion
CSII
Insulin Pump Therapy

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

ClinicalTrials.gov processed this record on May 22, 2013