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
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Feb 2006
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 14, 2010
CompletedFirst Posted
Study publicly available on registry
June 16, 2010
CompletedJune 16, 2010
June 1, 2010
3.1 years
June 14, 2010
June 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
ATP-Synthesis
liver lipid content
skeletal muscle lipid content
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Landsteiner Institutlead
- Mein Hanusch-Krankenhauscollaborator
- Karl-Landsteiner Institute for Endocrinology and Metabolismcollaborator
- Medical University of Viennacollaborator
- Lund Universitycollaborator
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italycollaborator
Study Sites (1)
Landsteiner Institute
Vienna, Vienna, 1140, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Roden, Prof.
Institute for Clinical Diabetology, German Diabetes Center (Leibniz Center for Diabetes Research), Department of Metabolic Diseases, Heinrich-Heine University and University Clinics Düsseldorf, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 14, 2010
First Posted
June 16, 2010
Study Start
February 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
June 16, 2010
Record last verified: 2010-06