The Effects of Short-time High-intensity Interval Trainin... | NCT01344928 | Trialant
NCT01344928
Sponsor
Turku University Hospital
Status
Unknown status
Last Update Posted
Apr 29, 2011Estimated
Enrollment
Not provided
Phase
Not Applicable
Conditions
Type 2 Diabetes Mellitus
Healthy Volunteers
Interventions
HIT exercise intervention
Aerobic exercise intervention
Countries
Finland
Protocol Section
Identification Module
NCT ID
NCT01344928
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
95/180/2010
Secondary IDs
Not provided
Brief Title
The Effects of Short-time High-intensity Interval Training on Tissue Glucose and Fat Metabolism in Healthy Subjects and Patients With Type 2 Diabetes
Official Title
Not provided
Acronym
HITPET
Organization
Turku University HospitalOTHER_GOV
Status Module
Record Verification Date
Apr 2011
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Not provided
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Apr 28, 2011
First Submission Date that Met QC Criteria
Apr 28, 2011
First Posted Date
Apr 29, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 28, 2011
Last Update Posted Date
Apr 29, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Turku University HospitalOTHER_GOV
Collaborators
Name
Class
European Foundation for the Study of Diabetes
OTHER
Ministry of Education and Culture, Finland
OTHER
Orion Farmos Research Foundation
UNKNOWN
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objectives of this study are to investigate the effects of short-time high-intensity interval training on tissue glucose and fat metabolism in healthy lean subjects and type 2 diabetic patients using modern and noninvasive imaging methods positron emission tomography (PET), magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS).
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes Mellitus
Healthy Volunteers
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
No data available
No data is available for this block.
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
HIT training
Experimental
Behavioral: HIT exercise intervention
Aerobic exercise training
Active Comparator
Behavioral: Aerobic exercise intervention
Interventions
Name
Type
Description
Arm Group Labels
Other Names
HIT exercise intervention
Behavioral
HIT training
Aerobic exercise intervention
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The healthy patients
Age 40-55
BMI 18.5-30
Fasting plasma glucose less than 6.1 mmol/l
Normal glucose tolerance test (OGTT)
The type 2 diabetic patients:
Age-, sex-, and BMI-matched with the study subjects in the phase 1
In a good treatment balance
Glycated haemoglobin (HbA1c) less than 7.5 mmol/l
Two hours glucose value in oral glucose tolerance test (OGTT) less than 10.0 mmol/l
Exclusion Criteria:
The healthy patients
Blood pressure > 140/90 mmHg
Any chronic disease
Any chronic medical defect or injury which hinder/interfere everyday life
History of anorexia nervosa or bulimia
History of rest or exercise-induced asthma
Previous use of anabolic steroids, additives or any other substrates
Smoking of tobacco, taking of snuffs, or use of narcotics.
Significant use of alcohol
Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
Presence of any ferromagnetic objects that would make MR imaging contraindicated
Current or history of regular and systematic exercise training
VO2max >40 ml/min/kg
The type 2 diabetic patients:
Any other chronic disease than diabetes
Blood pressure > 140/90 mmHg
Any chronic medical defect or injury which hinder/interfere everyday life
History of anorexia nervosa or bulimia
History of rest or exercise-induced asthma
Smoking of tobacco, taking of snuffs, or use of narcotics.
Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
Presence of any ferromagnetic objects that would make MRI imaging contraindicated
Current or history of regular and systematic exercise training
Ojala R, Motiani KK, Ivaska KK, Arponen M, Eskelinen JJ, Virtanen KA, Loyttyniemi E, Heiskanen MA, U-Din M, Nuutila P, Kalliokoski KK, Hannukainen JC. Bone Marrow Metabolism Is Impaired in Insulin Resistance and Improves After Exercise Training. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4290-303. doi: 10.1210/clinem/dgaa516.
Motiani KK, Collado MC, Eskelinen JJ, Virtanen KA, Loyttyniemi E, Salminen S, Nuutila P, Kalliokoski KK, Hannukainen JC. Exercise Training Modulates Gut Microbiota Profile and Improves Endotoxemia. Med Sci Sports Exerc. 2020 Jan;52(1):94-104. doi: 10.1249/MSS.0000000000002112.
Heiskanen MA, Motiani KK, Mari A, Saunavaara V, Eskelinen JJ, Virtanen KA, Koivumaki M, Loyttyniemi E, Nuutila P, Kalliokoski KK, Hannukainen JC. Exercise training decreases pancreatic fat content and improves beta cell function regardless of baseline glucose tolerance: a randomised controlled trial. Diabetologia. 2018 Aug;61(8):1817-1828. doi: 10.1007/s00125-018-4627-x. Epub 2018 May 2.