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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004296-35-GB

Enrollment

Registered

2007-09-03

Start date

2007-10-18

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 and pioglitazone.

Interventions

Trade Name: Actos Pharmaceutical Form: Tablet INN or Proposed INN: PIOGLITAZONE HYDROCHLORIDE CAS Number: 112529154 Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Eligibility

Sex/Gender

Male

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 PPAR agonists supralip 160 and pioglitazone.;Secondary Objective: To determine whether non-diabetic obese men display early indicators of cardiovascular disease and/or diabetes namely increased circulating levels of inflammatory chemicals, altered blood vessel function and changes in fat tissue composition. To determine whether supralip 160 and pioglitazone have effects on the early indicators of cardiovascular disease and/or diabetes listed above.;Primary end point(s): Peripheral / adipose monocyte inflammatory activation and insulin sensitivity	—

Measure

Time frame

Main Objective: 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 PPAR agonists supralip 160 and pioglitazone.;Secondary Objective: To determine whether non-diabetic obese men display early indicators of cardiovascular disease and/or diabetes namely increased circulating levels of inflammatory chemicals, altered blood vessel function and changes in fat tissue composition. To determine whether supralip 160 and pioglitazone have effects on the early indicators of cardiovascular disease and/or diabetes listed above.;Primary end point(s): Peripheral / adipose monocyte inflammatory activation and insulin sensitivity

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026