Type 2 Diabetes MellitusRECO2NCT01145092
Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes
A study testing exercise training, endurance training in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by Landsteiner Institut at 1 site in Austria.
Trial summary
Life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin Resistance
- What is being tested?
- exercise training, endurance training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2006to Mar 2009
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First degree relatives of type 2 diabetic patients
- Age: 18-50 years
- BMI <30 kg/m2 (due to limited MR diameter)
- Normal routine lab tests (blood cell count, kidney, liver, pancreas, thyroid and neuromuscular function)
- Availability within the local area throughout the study
- Ability to understand and sign the consent forms
Who cannot join
- Current smoking
- Present drug treatment
- Regular exercise training
- Contraindications for MRS studies: claustrophobia and metalliferous implants
- Pregnancy
- HIV or Hepatitis
Show all 13Show fewer
- Acute disease 2 weeks previous to the examination
- Heart disease
- Hypertension (RR>140/95)
- Liver disease
- Kidney disease
- Pulmonary disease
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an increased risk of developing diabetes.
Long-term endurance exercise training has been shown to increase insulin sensitivity in sedentary young and elderly individuals, first degree relatives of patients with Type 2 diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients, non-diabetic individuals with IGT and sedentary adults after exercise training of different intensity, different duration and different frequency an increase of insulin sensitivity was found.
However, despite the vast knowledge concerning beneficial effects physical activity for the prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health status the lack of time is the primary reason for the failure to exercise on a regular basis (or is stated as primary reason). Therefore the investigators aimed at investigating whether a controlled endurance/resistance training twice a week over 6 month might be beneficial for healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure parameters associated with the prevention of T2DM like insulin sensitivity, flux through fATPase and fCK, intramyocellular and hepatocellular lipids.
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Being tested
- exercise training, endurance training
- Keywords
- type 2 diabetes, exercise training, ATP-synthesis, intramyocellular lipids, hepatocellular lipids, first degree relatives of T2DM patients
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise training, endurance trainingBehavioural
The endurance training group exercised on a cycle ergometer (90% of power output determined at the respiratory compensation point = RCP). The duration of each training unit was increased with time. The resistance group trained on 8 weight machines where the workload gradually increased every 2-3 weeks. At week 13 an additional physical examination, OGTT and spiro-ergometry for adjusting the training were performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
measured by oral glucose tolerance test
Secondary outcomes (4)
incremental test power, oxygen uptake (VO2 in ml.kg-1.min-1), "aerobic threshold" (RCP= respiratory compensation point)
This test was performed on an electronically braked cycle ergometer
ATP-Synthesis
measured with 13C NMR
liver lipid content
measured with 1H NMR
skeletal muscle lipid content
measured by 1H NMR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startFeb 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landsteiner Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Mein Hanusch-Krankenhaus, Karl-Landsteiner Institute for Endocrinology and Metabolism, Medical University of Vienna, Lund University, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Investigators
- Michael Roden, Prof., Study director, Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145092
- Sponsor's protocol ID
- P15656
- Acronym
- RECO2
- Status last verified
- Jun 2010
- First submitted
- 14 Jun 2010
- Last updated
- 16 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01145092
- Acronym / sponsor ID
- RECO2 / P15656
- Conditions
- Type 2 Diabetes Mellitus, Insulin Resistance
- Keywords
- type 2 diabetes, exercise training, ATP-synthesis, intramyocellular lipids, hepatocellular lipids, first degree relatives of T2DM patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Landsteiner InstitutUniversity, hospital or other
- Collaborators
- Mein Hanusch-Krankenhaus, Karl-Landsteiner Institute for Endocrinology and Metabolism, Medical University of Vienna, Lund University, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- Feb 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Jun 2010 (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.
Life style intervention including diet and exercise is the recommended strategy for prevention of type 2 diabetes mellitus (T2DM). First-degree relatives of patients with type 2 diabetes mellitus have an increased risk of insulin resistance and a lifetime risk of developing type 2 diabetes of 40%- 80%. Poor physical fitness is a strong indicator of an increased risk of developing diabetes.
Long-term endurance exercise training has been shown to increase insulin sensitivity in sedentary young and elderly individuals, first degree relatives of patients with Type 2 diabetes, glucose intolerant obese, or Type 2 diabetic humans. In type 2 diabetic patients, non-diabetic individuals with IGT and sedentary adults after exercise training of different intensity, different duration and different frequency an increase of insulin sensitivity was found.
However, despite the vast knowledge concerning beneficial effects physical activity for the prevention of T2DM (and many other chronic metabolic disorders) to date wide ranging strategies have not been realized satisfactory. Regardless of age, ethnicity, sex or health status the lack of time is the primary reason for the failure to exercise on a regular basis (or is stated as primary reason). Therefore the investigators aimed at investigating whether a controlled endurance/resistance training twice a week over 6 month might be beneficial for healthy, non obese, first degree relatives with T2DM. Therefore the investigators measure parameters associated with the prevention of T2DM like insulin sensitivity, flux through fATPase and fCK, intramyocellular and hepatocellular lipids.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First degree relatives of type 2 diabetic patients
- Age: 18-50 years
- BMI <30 kg/m2 (due to limited MR diameter)
- Normal routine lab tests (blood cell count, kidney, liver, pancreas, thyroid and neuromuscular function)
- Availability within the local area throughout the study
Key exclusion criteria (13 listed)
- Current smoking
- Present drug treatment
- Regular exercise training
- Contraindications for MRS studies: claustrophobia and metalliferous implants
- Pregnancy
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 |
|---|---|---|
| exercise training, endurance trainingThe endurance training group exercised on a cycle ergometer (90% of power output determined at the respiratory compensation point = RCP). The duration of each training unit was increased with time. The resistance group trained on 8 weight machines where the workload gradually increased every 2-3 weeks. At week 13 an additional physical examination, OGTT and spiro-ergometry for adjusting the training were performed. | Behavioural | – |
Primary outcome
Insulin Sensitivity
measured by oral glucose tolerance test
4 secondary outcomes
incremental test power, oxygen uptake (VO2 in ml.kg-1.min-1), "aerobic threshold" (RCP= respiratory compensation point)
ATP-Synthesis
liver lipid content
skeletal muscle lipid content
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 16 Jun 2010.
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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.
Michael Roden, Prof. study director
Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training, endurance training in people with Type 2 Diabetes Mellitus and Insulin Resistance, run by Landsteiner Institut at 1 site in Austria.
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 6 inclusion and 13 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 16 Jun 2010. 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 Austria. 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?
Insulin Sensitivity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2010.