Chronic Inflammatory Activation in Fat Tissue: an Atherogenic Factor in Stable Coronary Artery Disease

NCT00510588 | Completed

• 1 other identifier: 0815-2007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. Aim of the 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 (Glitazon or Metformin) in obese patients with stable CAD and impaired glucose tolerance.

Conditions

Stable Coronary Artery Disease; Obesity; Impaired Glucose Tolerance

Keywords

adiposity

Outcome Measures

Primary Outcomes (1)

• change in endothelial function in patients with stable coronary artery disease

  6 months

Secondary Outcomes (1)

• change in metabolic parameters

  6 months

Study Arms (4)

1

OTHER

regular physical exercise training

Other: training

2

OTHER

regular physical exercise training + metformin

Other: training + metformin

3

OTHER

regular physical exercise training + glitazon

Other: training + glitazon

4

NO INTERVENTION

Control

Interventions

training OTHER

regular physical exercise training for 6 months

1

training + metformin OTHER

regular physical exercise training in combination with metformin for 6 months

2

training + glitazon OTHER

regular physical exercise training in combination with a glitazon for 6 months

3

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• diabetes mellitus type 1
• diabetes mellitus type 2 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
• indication for coronary artery bypass graft operation
• myocardial infarction within the last 3 months
• reduced left-ventricular systolic function \< 40 %

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University of Leipzig - heart center

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Obesity; Glucose Intolerance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

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: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DE (1)