Melatonin and Adiponectin in Hypertensive Kidney Transplant | NCT00498576

Studies
Melatonin and Adiponectin in Hypertensive Kidney Transplant

NCT00498576

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Jun 30, 2009Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Hypertension
Kidney Transplant

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 8, 2007

First Submission Date that Met QC Criteria

Jul 8, 2007

First Posted Date

Jul 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2009

Last Update Posted Date

Jun 30, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		kidney transplant with hypertension
2		hypertensive patients with native kidneys
3		healthy controls

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hypertension
kidney transplantation ( group 1)
good renal function

Exclusion Criteria:

diabetes mellitus
cancer
renal failure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

group1- patients from the kidney transplant unit, sheba medical center group2- patients from hypertension unit,sheba medical center

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Avshalom Leibowitz, MD		Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided