- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00282178
Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo
October 15, 2008 updated by: Umeå University
A 36 Week Three-Center Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Umeå, Sweden, SE-90185
- Umeå University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
|
Once daily
|
Active Comparator: 1
Candesartan 16-32 mg once daily
|
16-32 mg once daily 12 weeks
|
Active Comparator: 2
Hydrochlorothiazide 25-50 mg once daily
|
25-50 mg once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the effect of candesartan treatment with placebo on insulin sensitivity and compared with hydrochlorothiazide and placebo on:
Time Frame: 12 weeks
|
12 weeks
|
beta cell function
Time Frame: 12 weeks
|
12 weeks
|
vascular/endothelial function;
Time Frame: 12 weeks
|
12 weeks
|
lipolysis regulation
Time Frame: 12 weeks
|
12 weeks
|
autonomic nerve activity;
Time Frame: 12 weeks
|
12 weeks
|
abdominal fat tissue distribution;
Time Frame: 12 weeks
|
12 weeks
|
amount of lean body and fat mass;
Time Frame: 12 weeks
|
12 weeks
|
liver and muscle fat;
Time Frame: 12 weeks
|
12 weeks
|
interaction betw. insulin and AT-II in fat cell metabolism; fat cell gene expression
Time Frame: 12 weeks
|
12 weeks
|
adipokine levels
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Eriksson, MD, PhD, Dept of Medicine, Umeå University Hospital, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
January 24, 2006
First Submitted That Met QC Criteria
January 24, 2006
First Posted (Estimate)
January 25, 2006
Study Record Updates
Last Update Posted (Estimate)
October 16, 2008
Last Update Submitted That Met QC Criteria
October 15, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Hydrochlorothiazide
- Candesartan
Other Study ID Numbers
- D2452L00007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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