Studies of insulin action in patients at increased vascular risk. Modulation by antihypertensive and endocrine replacement therapy. - Studies of insulin action in patients at increased vascular risk

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001562-16-GB

Enrollment

Registered

2006-09-18

Start date

2006-11-01

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Protocol (a): Essential Hypertension Protocol (b): Hypertension in Type 2 Diabetes Protocol (c): Panhypopituitarism MedDRA version: 8.1 Level: LLT Classification code 10022489 Term: Insulin resistance

Interventions

Trade Name: Captopril 50mg Product Name: Captopril Product Code: 13311/0064 Pharmaceutical Form: Capsule* Trade Name: Bendroflumethiazi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -diabetes mellitus (except in protocol b where Hypertensive Type 2 diabetics are studied) -significant obesity (weight exceeding 125% of the ideal) -cardiac, renal or hepatic disease -history of gout -those receiving any treatment that may affect insulin action (except in protocol b) -patients with secondary hypertension -diastolic blood pressure outside 80-100mmHg range after placebo run-in of 6 weeks

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the effects of antihypertensive therapy (bendroflumethiazide vs placebo and bendroflumethiazide vs amlodipine) and endocrine replacement therapy (dehydroepiandrosterone vs placebo) on insulin resistance in patients that are at increased vascular risk.;Secondary Objective: Target insulin resistance as a vascular risk and look at ways of reducing it by modifying antihypertensive and endocrine therapies. ;Primary end point(s): Insulin resistance measured by hyperinsulinaemic euglycaemic glucose clamps.	—

Measure

Time frame

Main Objective: Assess the effects of antihypertensive therapy (bendroflumethiazide vs placebo and bendroflumethiazide vs amlodipine) and endocrine replacement therapy (dehydroepiandrosterone vs placebo) on insulin resistance in patients that are at increased vascular risk.;Secondary Objective: Target insulin resistance as a vascular risk and look at ways of reducing it by modifying antihypertensive and endocrine therapies. ;Primary end point(s): Insulin resistance measured by hyperinsulinaemic euglycaemic glucose clamps.

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Countries

United Kingdom

Outcome results

None listed

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