Effects of Six Months of Moderate Resistance- Versus Endurance-Training on Muscle ATP Synthesis in First-Degree Relatives of Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145092
• Other study ID #: P15656
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: June 15, 2010
• Start date: February 2006
• Est. completion date: March 2009

Study information

• Verified date: June 2010
• Source: Landsteiner Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical 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%. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• exercise training, endurance training
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.

Locations

Country	Name	City	State
Austria	Landsteiner Institute	Vienna

Sponsors (6)

Lead Sponsor	Collaborator
Landsteiner Institut	Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Hanusch Hospital, Karl-Landsteiner Institute for Endocrinology and Metabolism, Lund University, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	measured by oral glucose tolerance test		No
Secondary	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		No
Secondary	ATP-Synthesis	measured with 13C NMR		No
Secondary	liver lipid content	measured with 1H NMR		No
Secondary	skeletal muscle lipid content	measured by 1H NMR		No