Type 2 Diabetes MellitusHITPETNCT01344928
The Effects of Short-time High-intensity Interval Training on Tissue Glucose and Fat Metabolism in Healthy Subjects and Patients With Type 2 Diabetes
A study testing HIT exercise intervention and Aerobic exercise intervention in people with Type 2 Diabetes Mellitus and Healthy Volunteers, run by Turku University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Healthy Volunteers
- What is being tested?
- HIT exercise intervention and Aerobic exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Start not givento not given
- 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 40 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
- VO2max >40 ml/ min/kg
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku PET Centre
Turku, 20521
Jarna C Hannukainen, PhD, +358-2-3131878, jarna.hannukainen@tyks.fi
Jarna C Hannukainen, PhD
About this study
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).
- Conditions
- Type 2 Diabetes Mellitus, Healthy Volunteers
- Being tested
- HIT exercise intervention, Aerobic exercise intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIT exercise interventionBehavioural
Aerobic exercise interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| HIT training | Experimental | Not described Receives: Behavioral: HIT exercise intervention |
| Aerobic exercise training | Active comparator | Not described Receives: Behavioral: Aerobic exercise intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- European Foundation for the Study of Diabetes, Ministry of Education and Culture, Finland, Orion Farmos Research Foundation, Academy of Finland, Turku PET Centre, University of Turku, Verve Research, Oulu, Finland, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344928
- Sponsor's protocol ID
- 95/180/2010
- Acronym
- HITPET
- Status last verified
- Apr 2011
- First submitted
- 28 Apr 2011
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32785654Motiani 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.
PubMed 31425383Heiskanen 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.
PubMed 29717337
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01344928
- Acronym / sponsor ID
- HITPET / 95/180/2010
- Conditions
- Type 2 Diabetes Mellitus, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- European Foundation for the Study of Diabetes, Ministry of Education and Culture, Finland, Orion Farmos Research Foundation, Academy of Finland, Turku PET Centre, University of Turku, Verve Research, Oulu, Finland, University of Helsinki
- First posted
- 29 Apr 2011 (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 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).
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIT training | Experimental | Behavioral: HIT exercise intervention |
| Aerobic exercise training | Active comparator | Behavioral: Aerobic exercise intervention |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The healthy patients
- Age 40-55
- BMI 18.5-30
- Fasting plasma glucose less than 6.1 mmol/l
- Normal glucose tolerance test (OGTT)
Key exclusion criteria (24 listed)
- 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
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 |
|---|---|---|
| HIT exercise intervention | Behavioural | HIT training |
| Aerobic exercise intervention | Behavioural | Aerobic exercise training |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
- Derived from this study: PubMed 32785654Ojala 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.
- Derived from this study: PubMed 31425383Motiani 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.
- Derived from this study: PubMed 29717337Heiskanen 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.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIT exercise intervention and Aerobic exercise intervention in people with Type 2 Diabetes Mellitus and Healthy Volunteers, run by Turku University Hospital at 1 site in Finland.
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 10 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 29 Apr 2011. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01344928, which also lists 3 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 29 Apr 2011.