The Effects of Short-time High-intensity Interval Training on Tissue Glucose and Fat Metabolism in Healthy Subjects and Patients With Type 2 Diabetes (HITPET)

April 28, 2011 updated by: Turku University Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Finland
      • Turku, Finland, 20521
        • Recruiting
        • Turku PET Centre
        • Contact:
        • Principal Investigator:
          • Jarna C Hannukainen, PhD
        • Sub-Investigator:
          • Kari K Kalliokoski, PhD
        • Sub-Investigator:
          • Joonas J Eskelinen, BM
        • Sub-Investigator:
          • Anna Savolainen, BM
        • Sub-Investigator:
          • Ilkka Heinonen, PhD
        • Sub-Investigator:
          • Kirsi A Virtanen, PhD
        • Sub-Investigator:
          • Jukka Kemppainen, PhD
        • Sub-Investigator:
          • Juhani Knuuti, Professor
        • Sub-Investigator:
          • Pirjo Nuutila, Professor
        • Sub-Investigator:
          • Jussi Pärkkä, MD
        • Sub-Investigator:
          • Virva Lepomäki, MSc
        • Sub-Investigator:
          • Riitta Parkkola, MD, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

The healthy patients

  1. Age 40-55
  2. BMI 18.5-30
  3. Fasting plasma glucose less than 6.1 mmol/l
  4. Normal glucose tolerance test (OGTT)

The type 2 diabetic patients:

  1. Age-, sex-, and BMI-matched with the study subjects in the phase 1
  2. In a good treatment balance
  3. Glycated haemoglobin (HbA1c) less than 7.5 mmol/l
  4. Two hours glucose value in oral glucose tolerance test (OGTT) less than 10.0 mmol/l

Exclusion Criteria:

The healthy patients

  1. Blood pressure > 140/90 mmHg
  2. Any chronic disease
  3. Any chronic medical defect or injury which hinder/interfere everyday life
  4. History of anorexia nervosa or bulimia
  5. History of rest or exercise-induced asthma
  6. Previous use of anabolic steroids, additives or any other substrates
  7. Smoking of tobacco, taking of snuffs, or use of narcotics.
  8. Significant use of alcohol
  9. 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
  10. Presence of any ferromagnetic objects that would make MR imaging contraindicated
  11. Current or history of regular and systematic exercise training
  12. VO2max >40 ml/min/kg

The type 2 diabetic patients:

  1. Any other chronic disease than diabetes
  2. Blood pressure > 140/90 mmHg
  3. Any chronic medical defect or injury which hinder/interfere everyday life
  4. History of anorexia nervosa or bulimia
  5. History of rest or exercise-induced asthma
  6. Smoking of tobacco, taking of snuffs, or use of narcotics.
  7. 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
  8. Presence of any ferromagnetic objects that would make MRI imaging contraindicated
  9. Current or history of regular and systematic exercise training
  10. VO2max >40 ml/ min/kg

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?

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HIT training
Behavioral: HIT exercise intervention
Active Comparator: Aerobic exercise training
Behavioral: Aerobic exercise intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Turku University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Turku
University of Helsinki
Academy of Finland
European Foundation for the Study of Diabetes
Verve Research, Oulu, Finland
Ministry of Education and Culture, Finland
Orion Farmos Research Foundation
Turku PET Centre

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

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 Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 95/180/2010

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.

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