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Clinical Trials/EUCTR2006-004296-35-GB
EUCTR2006-004296-35-GB
Active, not recruiting
Phase 1

An investigation into the modulation of obesity associated monocyte/macrophage function, vascular inflammation and insulin resistance by PPAR agonist treatment

The Royal Group of Hospitals, Belfast Health and Social Care Trust0 sites80 target enrollmentSeptember 3, 2007
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ConditionsThe proposed study will investigate early indicators of cardiovascular disease and diabetes in healthy, obese men without a family history of diabetes and whether these are changed by treatment with the common PPAR agonists fenofibrate andpioglitazone.
DrugsActosSupralip 160

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
The proposed study will investigate early indicators of cardiovascular disease and diabetes in healthy, obese men without a family history of diabetes and whether these are changed by treatment with the common PPAR agonists fenofibrate andpioglitazone.
Sponsor
The Royal Group of Hospitals, Belfast Health and Social Care Trust
Enrollment
80
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 3, 2007
End Date
November 3, 2009
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
The Royal Group of Hospitals, Belfast Health and Social Care Trust

Eligibility Criteria

Inclusion Criteria

  • •Controls: male, 35\-65 years, BMI 20\-25 Kg/M2
  • •Cases: male, 35\-65 years, BMI \> 30 Kg/M2
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •cigarette smoking, clinical cardiac disease, plasma cholesterol \> 7 mmol/l, fasting
  • •triglycerides \> 5mmol/l, blood pressure \> 160/90 mmHg, diabetes/family history of diabetes, glucose intolerance or use of hypertensive; cardiac; vitamin; non\-steroidal anti\-inflammatory drugs or lipid\-lowering therapy

Outcomes

Primary Outcomes

Not specified

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