HypertensionNCT00498576
Melatonin and Adiponectin in Hypertensive Kidney Transplant
An observational study of Hypertension and Kidney Transplant, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome. We have also demonstrated that exogenic melatonin supplementation can improve blood pressure profile in nondipper patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Kidney Transplant
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to not given
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: group1- patients from the kidney transplant unit, sheba medical center group2- patients from hypertension unit,sheba medical center
Who may be able to join
- hypertension
- kidney transplantation ( group 1)
- good renal function
Who cannot join
- diabetes mellitus
- cancer
- renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome. We have also demonstrated that exogenic melatonin supplementation can improve blood pressure profile in nondipper patients.
The aim of this study is to find whether there is a difference between melatonin secretion in hypertensive kidney recipients versus "normal" hypertensive patients. Secondly, to ask if there is any correlation between melatonin secretion and adiponectin levels.
- Conditions
- Hypertension, Kidney Transplant
- Keywords
- hypertension, kidney transplant, melatonin, adiponectin
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | kidney transplant with hypertension | |
| 2 | hypertensive patients with native kidneys | |
| 3 | healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2007 (estimated)
- Study startSep 2007
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 Sheba Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Avshalom Leibowitz, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498576
- Sponsor's protocol ID
- SHEBA-07-4730-AL-CTIL
- Status last verified
- Jun 2009
- First submitted
- 8 Jul 2007
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin and Adiponectin in Hypertensive Kidney Transplant
- ClinicalTrials.gov ID
- NCT00498576
- Acronym / sponsor ID
- SHEBA-07-4730-AL-CTIL
- Conditions
- Hypertension, Kidney Transplant
- Keywords
- hypertension, kidney transplant, melatonin, adiponectin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2007
- First posted
- 10 Jul 2007 (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.
Recently we have shown that melatonin secretion is impaired in rats with metabolic syndrome. We have also demonstrated that exogenic melatonin supplementation can improve blood pressure profile in nondipper patients.
The aim of this study is to find whether there is a difference between melatonin secretion in hypertensive kidney recipients versus "normal" hypertensive patients. Secondly, to ask if there is any correlation between melatonin secretion and adiponectin levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –kidney transplant with hypertension |
| 2 | – | –hypertensive patients with native kidneys |
| 3 | – | –healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- group1- patients from the kidney transplant unit, sheba medical center group2- patients from hypertension unit,sheba medical center
Key inclusion criteria (3 listed)
- hypertension
- kidney transplantation ( group 1)
- good renal function
Key exclusion criteria (3 listed)
- diabetes mellitus
- cancer
- renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 30 Jun 2009.
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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.
Avshalom Leibowitz, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Kidney Transplant, run by Sheba Medical Center at 1 site in Israel.
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 3 inclusion and 3 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 30 Jun 2009. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 30 Jun 2009.