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| Sponsor: | Istituto Auxologico Italiano |
|---|---|
| Collaborators: |
Italian Society of Hypertension Italian Society of General Practitioners Yghea |
| Information provided by: | Istituto Auxologico Italiano |
| ClinicalTrials.gov Identifier: | NCT00456963 |
Purpose
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-receptor blockers (ARBs). Whether this difference is due to an antidiabetogenic action of ACEIs and ARBs or to the fact that these agents are free of the diabetogenic activity of ßBs and Ds is unknown. Prevention of DM as well as of HT is of primary health concern.
Objectives. The primary objective of PHIDIAS is to test whether in individuals with components of metabolic syndrome making them predisposed to DM and HT, addition of either an ACEI or an ARB to periodically reinforced lifestyle counselling can reduce 1) onset of DM and 2) onset of HT significantly more than lifestyle plus placebo. Secondary objectives are 1) comparing the antidiabetogenic effects of ACEI and ARB, and 2) investigating whether the effects of ACEI and ARB on DM and HT persist at least 6 months after treatment withdrawal.
Methods. PHIDIAS is a prospective, double-blind, placebo-controlled 3-arm comparison trial. 300 general practitioners (members of SIMG with the assistance of hospital centres of SIIA) will randomise 6000 untreated individuals aged 40-75 years, with SBP 130-139 or DBP 85-89 mmHg, fasting glucose (FG) 100-125 mg/dl, waist circumference >= 102 (M) or >= 88 cm (W), to three blinded treatments, given in addition to lifestyle advise: 1) Placebo; 2) the ACE Enalapril (10 mg, then 20 mg od); 3) the ARB Losartan (50 mg, then 100 mg od).Double-blind treatment will be maintained until 500 cases of DM are observed (presumably average of 36 months) (Treatment Phase: control visits, BP, FG every 6 months). This will be followed by a 6-month Withdrawal Phase (active treatment substituted by placebo). Primary outcomes are DM (FG >= 126 mg/dl) and HT (SBP >= 140 or DBP >= 90 mmHg) on 2 consecutive visits. PHIDIAS will be governed by a Steering Committee assisted by a blinded Event Adjudicating Committee and an independent DMSB.
Expected results. The sample size is adequate (alfa 5%, power 90%) to evaluate whether incident DM (expected rate 3.5%/year) or incident HT is reduced 25% by ACEI and ARB versus placebo (primary hypothesis) and whether either the ACEI or the ARB reduces incident DM by 30% more than the other agent.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Hypertension |
Behavioral: Diet Behavioral: Moderate exercise Drug: enalapril tablets Drug: placebo tablets Drug: Losartan Tablets |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Prevention of Hypertension Incidence and Diabetes Italian Assessment Study. Therapeutic Strategies of Prevention of Diabetes and Hypertension in Subjects With Metabolic Syndrome and High-Normal Blood Pressure. |
| Estimated Enrollment: | 3000 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Diet, exercise and Enalapril
one Enalapril 10mg tablet and one Losartan placebo tablet once daily for four weeks. Subsequentely one Enalapril 20mg tablet and one Losartan placebo tablet once daily until the end of the randomized treatment phase. After this one Enalapril placebo tablet and one Losartan placebo tablet once daily for six months.
|
Behavioral: Diet
total fat < 5%, saturated fat < 10%, vegetables, fruit
Behavioral: Moderate exercise
30 min at least 5 times/week
Drug: enalapril tablets
one Enalapril 10mg tablet once daily for four weeks. Subsequentely one Enalapril 20mg tablet once daily until the end of the randomized treatment phase
|
|
Active Comparator: Diet, Exercise and Losartan
one Losartan 50mg tablet and one Enalapril placebo tablet once daily for four weeks. Subsequentely one Losartan 100mg tablet and one Enalapril placebo tablet once daily until the end of the randomized treatment phase. After this one Losartan placebo tablet and one Enalapril placebo tablet once daily for six months.
|
Behavioral: Diet
total fat < 5%, saturated fat < 10%, vegetables, fruit
Behavioral: Moderate exercise
30 min at least 5 times/week
Drug: Losartan Tablets
one Losartan 50mg tablet once daily for four weeks. Subsequentely one Losartan 100mg tablet once daily until the end of the randomized treatment phase.
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|
Placebo Comparator: Diet, exercise and Placebo
one Enalapril placebo tablet and one Losartan placebo tablet once daily until study end.
|
Behavioral: Diet
total fat < 5%, saturated fat < 10%, vegetables, fruit
Behavioral: Moderate exercise
30 min at least 5 times/week
Drug: placebo tablets
one Enalapril placebo tablet and one Losartan placebo tablet once daily until study end.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Italy | |
| Istituto Auxologico Italiano. | |
| Milan, Italy, 20145 | |
| Principal Investigator: | Alberto Zanchetti, MD | Istituto Auxologico Italiano. Milan. Italy |
More Information
| Responsible Party: | Professor Alberto Zanchetti, Istituto Auxologico Italiano |
| ClinicalTrials.gov Identifier: | NCT00456963 History of Changes |
| Other Study ID Numbers: | FARM5JYE9K |
| Study First Received: | April 4, 2007 |
| Last Updated: | July 4, 2011 |
| Health Authority: | Italy: The Italian Medicines Agency |
|
angiotensin converting enzyme inhibitors angiotensin receptor blockers diabetes hypertension therapeutic strategies |
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Diabetes Mellitus Hypertension Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Angiotensin-Converting Enzyme Inhibitors Enalapril Enalaprilat Losartan |
Angiotensin Receptor Antagonists Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers |
