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

Obesity Clinical Trial

Official title:

A 36 Week Three-Center Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282178
• Other study ID #: D2452L00007
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: October 15, 2008
• Start date: April 2005
• Est. completion date: April 2006

Study information

• Verified date: June 2008
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Obesity

Intervention

Drug:
• Hydrochlorothiazide
25-50 mg once daily
• Placebo
Once daily
• Candesartan
16-32 mg once daily 12 weeks

Locations

Country	Name	City	State
Sweden	Umeå University Hospital	Umeå

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	AstraZeneca, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp		12 weeks	No
Secondary	Compare the effect of candesartan treatment with placebo on insulin sensitivity and compared with hydrochlorothiazide and placebo on:		12 weeks	No
Secondary	beta cell function		12 weeks	No
Secondary	vascular/endothelial function;		12 weeks
Secondary	lipolysis regulation		12 weeks	No
Secondary	autonomic nerve activity;		12 weeks	No
Secondary	abdominal fat tissue distribution;		12 weeks	No
Secondary	amount of lean body and fat mass;		12 weeks	No
Secondary	liver and muscle fat;		12 weeks	No
Secondary	interaction betw. insulin and AT-II in fat cell metabolism; fat cell gene expression		12 weeks	No
Secondary	adipokine levels		12 weeks	No