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

Phase 1

• 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

• Registration Number: EUCTR2006-001562-16-GB
• Lead Sponsor: Royal Group of Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-18
• Study Completion: 2009-05-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

-<65 years
-mild hypertension
-females with low levels of dehydroepiandrosterone for protocol (c)
-white western european origin
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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.