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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00282178
First Posted: January 25, 2006
Last Update Posted: October 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sahlgrenska University Hospital, Sweden
AstraZeneca
Information provided by:
Umeå University
  Purpose
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.

Condition Intervention Phase
Hypertension Obesity Drug: Hydrochlorothiazide Drug: Placebo Drug: Candesartan Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 36 Week Three-Center Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Compare the effect of candesartan treatment with placebo on insulin sensitivity and compared with hydrochlorothiazide and placebo on: [ Time Frame: 12 weeks ]
  • beta cell function [ Time Frame: 12 weeks ]
  • vascular/endothelial function; [ Time Frame: 12 weeks ]
  • lipolysis regulation [ Time Frame: 12 weeks ]
  • autonomic nerve activity; [ Time Frame: 12 weeks ]
  • abdominal fat tissue distribution; [ Time Frame: 12 weeks ]
  • amount of lean body and fat mass; [ Time Frame: 12 weeks ]
  • liver and muscle fat; [ Time Frame: 12 weeks ]
  • interaction betw. insulin and AT-II in fat cell metabolism; fat cell gene expression [ Time Frame: 12 weeks ]
  • adipokine levels [ Time Frame: 12 weeks ]

Enrollment: 26
Study Start Date: April 2005
Study Completion Date: April 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Candesartan 16-32 mg once daily
Drug: Candesartan
16-32 mg once daily 12 weeks
Active Comparator: 2
Hydrochlorothiazide 25-50 mg once daily
Drug: Hydrochlorothiazide
25-50 mg once daily
Placebo Comparator: 3 Drug: Placebo
Once daily

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00282178


Locations
Sweden
Umeå University Hospital
Umeå, Sweden, SE-90185
Sponsors and Collaborators
Umeå University
Sahlgrenska University Hospital, Sweden
AstraZeneca
Investigators
Principal Investigator: Jan Eriksson, MD, PhD Dept of Medicine, Umeå University Hospital, Sweden
  More Information

Responsible Party: Jan Eriksson, Umeå University Hospital
ClinicalTrials.gov Identifier: NCT00282178     History of Changes
Other Study ID Numbers: D2452L00007
First Submitted: January 24, 2006
First Posted: January 25, 2006
Last Update Posted: October 16, 2008
Last Verified: June 2008

Keywords provided by Umeå University:
Metabolic
Hypertension
Abdominal obesity
Insulin sensitivity
Hyperinsulinemic euglycemic clamp

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists