Status:
TERMINATED
Prevention of Diabetes and Hypertension
Lead Sponsor:
Istituto Auxologico Italiano
Collaborating Sponsors:
Italian Society of Hypertension
Italian Society of General Practitioners
Conditions:
Diabetes Mellitus
Hypertension
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
Background. Antihypertensive therapy with ß-blockers (ßBs) and diureticts (Ds) is accompanied by a higher incidence of diabetes mellitus (DM) than therapy with ACE-inhibitors (ACEIs) or angiotensin-re...
Detailed Description
1. Background and rationale 1. Evidence available Data obtained from observational studies have shown that subjects with hypertension have an increased prevalence of type II diabetes mellitus comp...
Eligibility Criteria
Inclusion
- Men or women of any racial background
- Age \>= 40 years and \<= 75 years
- SBP\>= 130 mmHg and \< 140 mmHg or DBP \>= 85 mmHg and \< 90 mmHg, average of screening and randomisation visits (in absence of any antihypertensive medication)
- FG \>=100 mg/dl (5.6 mmol/l) and \< 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication)
- Waist circumference \>= 102 cm in men and \>= 88 cm in women.
Exclusion
- SBP \>= 140 mmHg or DBP \>= 90 mmHg
- Any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation
- Any current or previous cardiovascular or renal disease requiring continuous administration of Ds, ßBs, ACEIs, ARBs, CAs, and any other antihypertensive medication
- Any medical condition preventing adherence to lifestyle measures included in the protocol
- Hepatic disease as AST (SGOT) or ALT (SGPT) values equal or greater than two times the upper limit of normal
- Chronic renal dysfunction as serum creatinine \> 2.0 mg/dl
- Any gastrointestinal disorder interfering with drug absorption
- Known allergy or contraindications to ACEIs or ARBs
- Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods
- Malignancy within the last 5 years
- Clinically significant autoimmune disorders
- Drug abuse or alcohol abuse within the last 5 years
- History of noncompliance to medical regimens
- Incapacity or unwillingness to sign the informed consent
- Participation in any investigational clinical trial within the last 3 months
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00456963
Start Date
September 1 2007
End Date
March 1 2010
Last Update
February 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istituto Auxologico Italiano.
Milan, Italy, 20145