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Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo

NCT ID: NCT00282178

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-04-30

Brief Summary

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The purpose of this study is to investigate the effect of a 12-week candesartan treatment compared with hydrochlorothiazide on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp.

Detailed Description

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To investigate the mechanisms underlaying the diabetes-preventing effect of candesartan with respect to possible impact on insulin sensitivity, beta cell function and adipose tissue function and distribution. For this purpose comparisons will be performed with hydrochlorothiazide and placebo treatment. It is hypothesized that candesartan will improve insulin sensitivity as compared to hydrochlorothiazide and possibly also in comparison with placebo and that this could be explained by altered fat tissue function or distribution or by an altered sympathetic to parasympathetic balance in the autonomic nervous system. Hydrochlorthiazide is chosen as comparator because thiazides are a recommended firs-line therapy in hypertension. This drug class has some detrimental effects on glucose tolerance and in insulin sensitivity.

Conditions

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Hypertension Obesity

Keywords

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Metabolic Hypertension Abdominal obesity Insulin sensitivity Hyperinsulinemic euglycemic clamp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Candesartan 16-32 mg once daily

Group Type ACTIVE_COMPARATOR

Candesartan

Intervention Type DRUG

16-32 mg once daily 12 weeks

2

Hydrochlorothiazide 25-50 mg once daily

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

25-50 mg once daily

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily

Interventions

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Hydrochlorothiazide

25-50 mg once daily

Intervention Type DRUG

Placebo

Once daily

Intervention Type DRUG

Candesartan

16-32 mg once daily 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female 18-70 years old
* Diagnosed hypertension and abdominal obesity (waist circumference greater than or equal to 102 cm (M) or 88 cm (F)

Exclusion Criteria

* Uncontrolled hypertension
* Treatment with more than two concomitant antihypertensive medications
* Diabetes Mellitus
* Other endocrine disorder
* Severe liver disease
* Severely reduced renal function
* Malignant disease
* Alcohol or drug abuse
* Severe psychiatric illness
* History of stroke, myocardial infarction, unstable angina pectoris, participation in another clinical trial less than two months prior to screening visit
* treatment with anti-obesity drugs
* anti-inflammatory drugs or immunosuppressive drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Umeå University Hospital

Principal Investigators

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Jan Eriksson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Medicine, Umeå University Hospital, Sweden

Locations

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Umeå University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D2452L00007

Identifier Type: -

Identifier Source: org_study_id