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

Umeå University

Status and phase: Completed; Phase 2

Conditions: Hypertension; Obesity

Treatments: Drug: Hydrochlorothiazide; Drug: Placebo; Drug: Candesartan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00282178

D2452L00007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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26 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Candesartan 16-32 mg once daily

Treatment:

Drug: Candesartan

2

Active Comparator group

Description:

Hydrochlorothiazide 25-50 mg once daily

Treatment:

Drug: Hydrochlorothiazide

3

Placebo Comparator group

Treatment:

Drug: Placebo