NCT00510705

Brief Summary

Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

November 27, 2020

Status Verified

December 1, 2014

Enrollment Period

5 years

First QC Date

August 1, 2007

Last Update Submit

November 23, 2020

Conditions

Severe Coronary Artery DiseaseObesityImpaired Glucose Tolerance

Keywords

adiposity

Outcome Measures

Primary Outcomes (1)

  • change in endothelial function in severe coronary artery disease

    4 weeks

Secondary Outcomes (1)

  • change in metabolic parameters

    4 weeks

Study Arms (4)

1

OTHER

Regular physical exercise training alone

Other: exercise training

2

OTHER

Regular physical exercise training + metformin

Other: exercise training + metformin

3

OTHER

Regular physical exercise training + glitazone

Other: exercise training + glitazone

4

NO INTERVENTION

Control

Interventions

exercise trainingOTHER

physical exercise training on a bicycle ergometer daily for 4 weeks

1
exercise training + metforminOTHER

physical exercise training on a bicycle ergometer + metformin (2 x 850 mg) daily for 4 weeks

2
exercise training + glitazoneOTHER

physical exercise training on a bicycle ergometer + glitazone daily for 4 weeks

3

Eligibility Criteria

Age35 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Either impaired glucose tolerance (2 hour plasma glucose concentration \> 7.8 and \< 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( \> 6.0 and \< 7.0 mmol/L)
  • Body mass index (BMI) \> 25
  • Severe coronary artery disease determined by coronary angiography
  • Male patients aged 35-75 years

You may not qualify if:

  • Diabetes mellitus type I
  • Diabetes mellitus type II in combination with glycosylates hemoglobin \> 6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \> 11.0 mmol/L
  • Unstable angina pectoris
  • Myocardial infarction within the last 4 weeks
  • Reduced left-ventricular systolic function \< 30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Coronary Artery DiseaseObesityGlucose Intolerance

Interventions

ExerciseMetforminThiazolidinediones

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperglycemiaGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaBiguanidesGuanidinesAmidinesOrganic ChemicalsThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gerhard Schuler, Prof. of Medicine

    Heart Center Leipzig - University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2012

Last Updated

November 27, 2020

Record last verified: 2014-12

Locations

DE(1)