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OpenTrials
Completed

NCT Number: NCT00638560

Changes of Biomarkers in Response to Training and Antioxidant Treatment

The aim of the study is to compare the effects of an intensive 4 weeks exercise training program with or without additional treatment with antioxidants. 16 volunteers are included into the study and randomized into a treatment (n=8,Vitamine E 400 IU od + vitamine C 1g twice daily) and a non-treatment (n=8, training only) group. Before and after the training program, skeletal muscle biopsies will be taken to measure PGC-1alpha and PPARgamma mRNA expression. In addition before and after the training program individuals will have the following measurements: body weight, waist circumference, body fat content (DEXA scan), euglycemic-hyperinsulinemic clamps, ergospirometer (VO2 max), routine laboratory measurements, serum malondialdehyde concentrations.

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Key information

Conditions

Obesity Body Weight Carotid Intimal Medial Thickness 1 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

25 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Leipzig

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to swallow tablets
  • signed informed consent
  • no concommitant medication
  • male
  • age between 25 - 35 years

Exclusion criteria

  • drug, tobacco or alcohol abuse
  • any chronic disease
  • any acute or chronic inflammatory disease as determined by a leucocyte count > 7000 Gpt/l, C-reactive protein (CrP) > 5.0 mg/dl or clinical signs of infection
  • systolic blood pressure (SBP) > 140mmHg and diastolic blood pressure (DBP) was > 85mmHg
  • cardiovascular or peripheral artery disease
  • thyroid dysfunction

Treatment and study plan

Vitamin C, Vitamin E

Dietary Supplement

Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily

Antioxidant treatment

Dietary Supplement

no treatment

Primary outcomes

  1. PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration

    Time frame: after 4 weeks

Secondary outcomes

  1. body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • University of Jena

Registry information

Official study title

Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 19, 2008
Registry last updated
Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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