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Changes of Biomarkers in Response to Training and Antioxidant Treatment

This study has been completed.
Sponsor:
Collaborator:
University of Jena
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00638560
First received: March 12, 2008
Last updated: January 19, 2010
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Obesity
Type 2 Diabetes
Dietary Supplement: Vitamin C, Vitamin E
Dietary Supplement: Antioxidant treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Training and Antioxidant Treatment on Circulating Markers of Oxidative Stress and Skeletal Muscle mRNA Expression

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration [ Time Frame: after 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Antioxidant treatment arm:

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

Dietary Supplement: Vitamin C, Vitamin E
Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily
Placebo Comparator: 2
Control
Dietary Supplement: Antioxidant treatment
no treatment

  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638560

Locations
Germany
University of Leipzig
Leipzig, Germany, 04103
Sponsors and Collaborators
University of Leipzig
University of Jena
Investigators
Principal Investigator: Matthias Blüher, MD University of Leipzig
  More Information

No publications provided by University of Leipzig

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Matthias Blüher, Medical Department, University of Leipzig
ClinicalTrials.gov Identifier: NCT00638560     History of Changes
Other Study ID Numbers: MB-MR-2008-290208
Study First Received: March 12, 2008
Last Updated: January 19, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
PGC-1alpha
PPARgamma
oxidative stress
training intervention

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Alpha-Tocopherol
Antioxidants
Ascorbic Acid
Tocopherols
Tocotrienols
Vitamin E
Vitamins
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 27, 2014