Type 1 Diabetes MellitusNCT02204839
Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM
A study testing Basal insulin dose in people with Type 1 Diabetes Mellitus, run by Northumbria University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Basal insulin dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility, Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
About this study
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
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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Basal insulin dose
- Keywords
- T1DM, Exercise, Hypoglycaemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basal insulin doseDrug
Also called (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)
| Study group | Role | What they receive |
|---|---|---|
| Basal dose reduction | Experimental | Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose. Receives: Drug: Basal insulin dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour blood glucose area under the curve
24 hour blood glucose area under the curve
Measured: 24 hours
Secondary outcomes (1)
Ketonaemia
Blood beta-hydroxybutyrate concentrations
Measured: 60 minutes before and 24 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- Daniel J West, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204839
- Sponsor's protocol ID
- West-Walker3
- Status last verified
- Jan 2015
- First submitted
- 25 Jul 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35673512Campbell 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.
PubMed 26019878
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02204839
- Acronym / sponsor ID
- West-Walker3
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1DM, Exercise, Hypoglycaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basal dose reduction | Experimental | Drug: Basal insulin doseTotal daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basal insulin doseAlso: (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) | Drug | Basal dose reduction |
Primary outcome
24 hour blood glucose area under the curve
Time frame: 24 hours
24 hour blood glucose area under the curve
1 secondary outcome
Ketonaemia
Time frame: 60 minutes before and 24 hours post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Derived from this study: PubMed 35673512Campbell 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.
- Derived from this study: PubMed 26019878Campbell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J West, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basal insulin dose in people with Type 1 Diabetes Mellitus, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour blood glucose area under the curve (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204839, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.