HypertensionPhase 2NCT00282178
Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo
A Phase 2 study testing Hydrochlorothiazide and Candesartan in people with Hypertension and Obesity, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension, Obesity
- What is being tested?
- Hydrochlorothiazide and Candesartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Uncontrolled hypertension
- Treatment with more than two concomitant antihypertensive medications
- Diabetes Mellitus
- Other endocrine disorder
- Severe liver disease
- Severely reduced renal function
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Obesity
- Being tested
- Hydrochlorothiazide, Placebo, Candesartan
- Keywords
- Metabolic, Hypertension, Abdominal obesity, Insulin sensitivity, Hyperinsulinemic euglycemic clamp
- Medical subject headings
- Hypertension, Obesity, Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochlorothiazideDrug
25-50 mg once daily
PlaceboDrug
Once daily
CandesartanDrug
16-32 mg once daily 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Candesartan 16-32 mg once daily Receives: Drug: Candesartan |
| 2 | Active comparator | Hydrochlorothiazide 25-50 mg once daily Receives: Drug: Hydrochlorothiazide |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp
Measured: 12 weeks
Secondary outcomes (10)
Compare the effect of candesartan treatment with placebo on insulin sensitivity and compared with hydrochlorothiazide and placebo on:
Measured: 12 weeks
beta cell function
Measured: 12 weeks
vascular/endothelial function;
Measured: 12 weeks
lipolysis regulation
Measured: 12 weeks
autonomic nerve activity;
Measured: 12 weeks
abdominal fat tissue distribution;
Measured: 12 weeks
amount of lean body and fat mass;
Measured: 12 weeks
liver and muscle fat;
Measured: 12 weeks
interaction betw. insulin and AT-II in fat cell metabolism; fat cell gene expression
Measured: 12 weeks
adipokine levels
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startApr 2005
- Primary completionMar 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, AstraZeneca
- Investigators
- Jan Eriksson, MD, PhD, Principal investigator, Dept of Medicine, Umeå University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282178
- Sponsor's protocol ID
- D2452L00007
- Status last verified
- Jun 2008
- First submitted
- 24 Jan 2006
- Last updated
- 16 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 36 Week Three-Center Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo
- ClinicalTrials.gov ID
- NCT00282178
- Acronym / sponsor ID
- D2452L00007
- Conditions
- Hypertension, Obesity
- Keywords
- Metabolic, Hypertension, Abdominal obesity, Insulin sensitivity, Hyperinsulinemic euglycemic clamp
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, AstraZeneca
- Study start
- Apr 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 25 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CandesartanCandesartan 16-32 mg once daily |
| 2 | Active comparator | Drug: HydrochlorothiazideHydrochlorothiazide 25-50 mg once daily |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- Uncontrolled hypertension
- Treatment with more than two concomitant antihypertensive medications
- Diabetes Mellitus
- Other endocrine disorder
- Severe liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrochlorothiazide25-50 mg once daily | Drug | 2 |
| PlaceboOnce daily | Drug | 3 |
| Candesartan16-32 mg once daily 12 weeks | Drug | 1 |
Primary outcome
Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp
Time frame: 12 weeks
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Eriksson, MD, PhD principal investigator
Dept of Medicine, Umeå University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrochlorothiazide and Candesartan in people with Hypertension and Obesity, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2008.