Changes of Biomarkers in Response to Training and Antioxi... | NCT00638560

Studies
Changes of Biomarkers in Response to Training and Antioxidant Treatment

NCT00638560

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Jan 20, 2010Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Obesity
Type 2 Diabetes

Interventions

Vitamin C, Vitamin E
Antioxidant treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Mar 12, 2008

First Submission Date that Met QC Criteria

Mar 12, 2008

First Posted Date

Mar 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2010

Last Update Posted Date

Jan 20, 2010Estimated

Name	Class
University of Jena	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Antioxidant treatment arm: Vitamin E, 400 IU po, once daily Vitamin C, 1g po, twice daily	Dietary Supplement: Vitamin C, Vitamin E
2	Placebo Comparator	Control	Dietary Supplement: Antioxidant treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin C, Vitamin E	Dietary Supplement	Vitamin C, 1g po, twice daily Vitamin E, 400 IU po, once daily	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PGC-1alpha mRNA expression in skeletal muscle PPARgamma mRNA expression in skeletal muscle Serum malondialdehyde concentration		after 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
body weight glucose infusion rate during the steady state of an euglycemic-hyperinsulinemic clamp VO2max		4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthias Blüher, MD	University of Leipzig	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig		Leipzig		04103	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19433800	Derived	Ristow M, Zarse K, Oberbach A, Kloting N, Birringer M, Kiehntopf M, Stumvoll M, Kahn CR, Bluher M. Antioxidants prevent health-promoting effects of physical exercise in humans. Proc Natl Acad Sci U S A. 2009 May 26;106(21):8665-70. doi: 10.1073/pnas.0903485106. Epub 2009 May 11.

ID	Term
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
C563733	Carotid Intimal Medial Thickness 1

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D001205	Ascorbic Acid
D014810	Vitamin E

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals