Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes (RECO2)
Primary Purpose
Type 2 Diabetes Mellitus, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
exercise training, endurance training
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes, exercise training, ATP-synthesis, intramyocellular lipids, hepatocellular lipids, first degree relatives of T2DM patients
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Current smoking
- Present drug treatment
- Regular exercise training
- Contraindications for MRS studies: claustrophobia and metalliferous implants
- Pregnancy
- HIV or Hepatitis
- Acute disease 2 weeks previous to the examination
- Heart disease
- Hypertension (RR>140/95)
- Liver disease
- Kidney disease
- Pulmonary disease
- Thyroid disease
Sites / Locations
- Landsteiner Institute
Outcomes
Primary Outcome Measures
Insulin Sensitivity
measured by oral glucose tolerance test
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01145092
First Posted
June 14, 2010
Last Updated
June 15, 2010
Sponsor
Landsteiner Institut
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
1. Study Identification
Unique Protocol Identification Number
NCT01145092
Brief 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
Acronym
RECO2
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Landsteiner Institut
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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%. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Insulin Resistance
Keywords
type 2 diabetes, exercise training, ATP-synthesis, intramyocellular lipids, hepatocellular lipids, first degree relatives of T2DM patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
exercise training, endurance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
measured by oral glucose tolerance test
Secondary Outcome Measure Information:
Title
incremental test power, oxygen uptake (VO2 in ml.kg-1.min-1), "aerobic threshold" (RCP= respiratory compensation point)
Description
This test was performed on an electronically braked cycle ergometer
Title
ATP-Synthesis
Description
measured with 13C NMR
Title
liver lipid content
Description
measured with 1H NMR
Title
skeletal muscle lipid content
Description
measured by 1H NMR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Current smoking
Present drug treatment
Regular exercise training
Contraindications for MRS studies: claustrophobia and metalliferous implants
Pregnancy
HIV or Hepatitis
Acute disease 2 weeks previous to the examination
Heart disease
Hypertension (RR>140/95)
Liver disease
Kidney disease
Pulmonary disease
Thyroid disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Roden, Prof.
Organizational Affiliation
Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Landsteiner Institute
City
Vienna
ZIP/Postal Code
1140
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes
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