- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544684
Fasted Exercise in People With Type 1 Diabetes
June 7, 2018 updated by: Sam Shepherd, Liverpool John Moores University
Fasted High-Intensity Interval and Moderate-Intensity Continuous Exercise Are Not Associated With A Detrimental 24-Hour Blood Glucose Profile
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period.
Fourteen people with type 1 diabetes (duration of type 1 diabetes 8.2±1.4 years), all on basal-bolus regimen, completed a randomised, counterbalanced, crossover study.
Continuous glucose monitoring was used to assess glycaemic control following a single bout of HIT (6 x 1min intervals) and 30 mins of moderate-intensity continuous training (MICT) on separate days, compared to a non-exercise control day (CON).
Exercise was undertaken following an overnight fast with omission of short-acting insulin.
Capillary blood glucose samples were recorded pre and post-exercise to assess the acute changes in glycaemia during HIT and MICT.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L3 3AF
- Liverpool John Moores University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- duration of type 1 diabetes >6 months
- basal bolus regimen
- no significant history of hyper- or hypoglycaemia (determined from medical history
Exclusion Criteria:
- duration of type 1 diabetes <6 months,
- insulin pump therapy
- significant history of hyper- or hypoglycaemia (determined from medical history)
- obesity (BMI >30 kg∙m-2)
- pregnancy or planning pregnancy, uncontrolled hypertension (>180/100 mmHg)
- angina
- autonomic neuropathy
- taking any medication that affects heart rate
- major surgery planned within 6 weeks of the study
- severe nonproliferative and
- unstable proliferative retinopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control day with no exercise
glycaemic profile will be assessed using continuous glucose monitors following a single 24-hour period in which participants performed no exercise
|
glucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training
|
Experimental: High intensity interval training (HIT)
glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of high-intensity interval training (HIT) in the morning under fasted conditions
|
glucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training
|
Experimental: moderate intensity continuous training (MICT)
glycaemic profile will be assessed using continuous glucose monitors following a 24-hour period whereby participants performed a single bout of moderate-intensity continuous training (MICT) in the morning under fasted conditions
|
glucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24 hour glycaemic profile
Time Frame: 24 hours
|
Continuous glucose monitoring will be used to assess the effects of an acute bout of fasted high intensity interval training or moderate intensity continuous training on 24 hour glycaemic profile.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. High-Intensity Interval Training Improves Aerobic Capacity Without a Detrimental Decline in Blood Glucose in People With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Feb 1;104(2):604-612. doi: 10.1210/jc.2018-01309.
- Scott SN, Cocks M, Andrews RC, Narendran P, Purewal TS, Cuthbertson DJ, Wagenmakers AJM, Shepherd SO. Fasted High-Intensity Interval and Moderate-Intensity Exercise Do Not Lead to Detrimental 24-Hour Blood Glucose Profiles. J Clin Endocrinol Metab. 2019 Jan 1;104(1):111-117. doi: 10.1210/jc.2018-01308.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2015
Primary Completion (Actual)
October 10, 2017
Study Completion (Actual)
October 10, 2017
Study Registration Dates
First Submitted
May 9, 2018
First Submitted That Met QC Criteria
May 21, 2018
First Posted (Actual)
June 4, 2018
Study Record Updates
Last Update Posted (Actual)
June 11, 2018
Last Update Submitted That Met QC Criteria
June 7, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1D_PARTA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no plan to make individual data available to others
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Type1diabetes
-
Silesian Centre for Heart DiseasesThe Jerzy Kukuczka Academy of Physical Education in KatowiceCompletedtype1diabetesPoland
-
Vastra Gotaland RegionCompletedType1diabetesSweden
-
Rabin Medical CenterThe Leona M. and Harry B. Helmsley Charitable Trust; DreaMed DiabetesRecruiting
-
University of Southern CaliforniaThe Leona M. and Harry B. Helmsley Charitable TrustCompletedType1diabetesUnited States
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)Active, not recruiting
-
Aalborg University HospitalAalborg University; Steno Diabetes Center NordjyllandCompletedType1diabetes | Hemodialysis | Type2DiabetesDenmark
-
Vastra Gotaland RegionRecruitingType1diabetes | Psychology Functional BehaviorSweden
-
Radboud University Medical CenterUnknownType1diabetes | Hypoglycemia UnawarenessNetherlands
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Active, not recruitingHypoglycemia | Type1diabetes | Islet Cell Transplantation | Hypoglycemia UnawarenessUnited States
-
University of British ColumbiaJuvenile Diabetes Research Foundation; Brain CanadaNot yet recruiting
Clinical Trials on Effects of the type of exercise on blood glucose concentrations
-
Institut fur Diabetes Karlsburg GmbHTyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053...Completed
-
Institut fur Diabetes Karlsburg GmbHTyson Bioresearch Inc., Kedong 3rd Rd., Zhunan Township, Miaoli County 35053...Completed
-
University of Illinois at ChicagoRecruitingDepression | Fatigue | Chronic Pain | Acute PainUnited States
-
National Taiwan University HospitalNational Taiwan Normal UniversityCompletedElderly | Exercise TrainingTaiwan
-
Aylin KurtRecruitingChildren, Only | Fear Anxiety | Hospitalism in ChildrenTurkey
-
University of Illinois at ChicagoCompletedDepression | Brain Injuries | Acute Pain | Chronic Pain Due to InjuryUnited States
-
Centre Hospitalier Universitaire DijonCompleted
-
Nantes University HospitalUnknownAcute Circulatory FailureFrance
-
Nere MendizabalNot yet recruiting
-
University Hospital, GrenobleCompletedHealthy Volunteers | Chronic Obstructive Pulmonary Disease (COPD) | Sleep Apnea Obstructive (OSA)France