EVALUATION OF THE RELATIONSHIP BETWEEN INFLAMMATION-PHYSICAL ACTIVITY AND THE ACTIVITY OF THE HYPOTHALAMIC-PITUITARY-ADRENAL AXIS - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002600-18-IT

Enrollment

Registered

2007-06-18

Start date

2007-06-05

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Abdominal obesity with metabolic syndrome MedDRA version: 6.1 Level: PT Classification code 10052066

Interventions

Trade Name: CARDIOASPIRIN*30CPR GAST 100MG Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Acetylsalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: One-hundred obese women (30Body Mass Index34.9 Kg/ m2) with abdominal body fat distribution (Waist to Hip ratio-WHR >0.85 e waist circumference > 88 cm) will be enrolled in the study. All women must have regular menses and must be aged between 25 and 45 years, in order to avoid bias on physical activity. Obese women must have one or more alterations of metabolic syndrome. 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: Basing on physical examination, individual clinical history and lab tests, women suffered of diabetes, thyroid diseases, Cushing's syndrome, hyperandrogenism or systemic diseases will be excluded. Tendency to bleeding, estrogen treatment or pregnancy will be considered exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: This is a study of physiopatology that has to investigate the effect of physical activity, associated to low calorie diet regimen, on both the activity of the hypothalamic-pituitary-adrenal axis and inflammation and peripheral insulin sensibility.;Secondary Objective: The study will evaluate the eventual additive effect of aspirin treatment on the same parameters. These data will give informations about the relationship between the acute-phase proteins, cytokines, glucocorticoids and physical activity;Primary end point(s): Evaluation of physical activity effect alone or in combination with pharmacological treatment (aspirin) on flogosis and, then, on the activity of the HPA axis (urinary free cortisol excretion)	—

Measure

Time frame

Main Objective: This is a study of physiopatology that has to investigate the effect of physical activity, associated to low calorie diet regimen, on both the activity of the hypothalamic-pituitary-adrenal axis and inflammation and peripheral insulin sensibility.;Secondary Objective: The study will evaluate the eventual additive effect of aspirin treatment on the same parameters. These data will give informations about the relationship between the acute-phase proteins, cytokines, glucocorticoids and physical activity;Primary end point(s): Evaluation of physical activity effect alone or in combination with pharmacological treatment (aspirin) on flogosis and, then, on the activity of the HPA axis (urinary free cortisol excretion)

—

Countries

Italy

Outcome results

None listed

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