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Study the role of dopamine receptors on the structure and function of endothelial primary cilia in vitro and in vivo

Protocol summary

Summary
In this trial we hypothesize that abnormal endothelial cilia in adult polycystic Kidney Disease (PKD) patients would have abnormal Nitric Oxide (NO) biosynthesis. Consequently, the trial objectives are the stimulation of ciliary dopamine receptor with dopaminergic agent (Levodopa) in PKD patients to: 1) restore NO biosynthesis and 2) correct their blood pressure. Inclusion criteria: adult type polycystic kidney disease with borderline hypertension; Control group inclusion criteria are essential borderline hypertension (HTN) without any secondary cause and are age-matched with PKD group. Exclusion criteria are: Pregnancy, lactation, diabetes mellitus, myocardial infarction, angina, arrhythmias, renal transplantation, renal failure, serum creatinin more than 3mg/dL, dialysis, sever hypertension, recieving antihypertensive drugs. Study population: Adult Polycystic Kidney Disease (PKD) Sample size: 30 patients The intervention drug is levodopa (as the metabolic precursor of dopamine) to stimulate ciliary dopamine receptor. Main outcome measures are serum nitric oxide and blood pressure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110611384N1
Registration date: 2012-12-03, 1391/09/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-12-03, 1391/09/13
Registrant information
Name
Sarmed Kathem
Name of organization / entity
College of Pharmacy-University of Baghdad
Country
Iraq
Phone
1 009644164988
Email address
sarmed.kathem11@utoledo.edu
Recruitment status
Recruitment complete
Funding source
College of Pharmacy-University of Baghdad
Expected recruitment start date
2012-06-01, 1391/03/12
Expected recruitment end date
2012-09-30, 1391/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the role of dopamine receptors on the structure and function of endothelial primary cilia in vitro and in vivo
Public title
Dopamine receptor in hypertension with Polycystic Kidney Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adult type polycystic kidney disease with borderline hypertension; Control group inclusion criteria are essential borderline hypertension without any secondary cause. Exclusion criteria are: Pregnancy, lactation, diabetes mellitus, myocardial infarction, angina, arrhythmias, renal transplantation, renal failure, serum creatinin more than 3mg/dL, dialysis, sever hypertension, recieving antihypertensive drugs.
Age
From 25 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of College of Pharmacy- graduate study committee
Street address
Babalmouadhum 14026
City
Baghdad
Postal code
Approval date
2012-05-22, 1391/03/02
Ethics committee reference number
2684

Health conditions studied

1

Description of health condition studied
Adult Polycystic Kidney Disease
ICD-10 code
Q61.2
ICD-10 code description
Polycystic kidney, autosomal dominant Polycystic kidney, adult type

Primary outcomes

1

Description
Blood Pressure
Timepoint
0 hour, 2 hours, 7 days
Method of measurement
mercury sphygmomanometer

2

Description
Serum Nitric Oxide
Timepoint
0 hour, 7 days
Method of measurement
serum detection by Greiss reaction (colorimetric)

Secondary outcomes

1

Description
Heart rate
Timepoint
0 hour, 2 hour, 7 days
Method of measurement
radial pulse method

2

Description
Assymetric dimethylarginine
Timepoint
0 hour, 7 days
Method of measurement
serum samples by ELISA

3

Description
Serum Creatinin
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

4

Description
Urea
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

5

Description
calcium
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

6

Description
sodium
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

7

Description
Potassium
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

8

Description
Albumin
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

9

Description
Alanine Aminotransferase
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

10

Description
Aspartate Aminotransferase
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

11

Description
Alkaline Phosphatase
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

12

Description
Total Bilirubin
Timepoint
0 hour, 7 days
Method of measurement
serum sample by ready made kit

13

Description
Body Mass Index
Timepoint
baseline
Method of measurement
Weight (kg)/Height (sequare meter)

Intervention groups

1

Description
Levodopa 50 mg capsule three times daily for 7 days; Domperidone 20 mg to reduce nausea used 30 minutes before Levodopa dose for 7 days
Category
Treatment - Drugs

2

Description
Levodopa 100 mg capsule, three times daily for 7 days; Domperidone 20 mg to reduce nausea used 30 minutes before levodopa dose for 7 days
Category
Treatment - Drugs

3

Description
control, placebo capsule three times daily for 7 days; domperidone 20 mg also used in this group to simulate drug group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Alkadhumia Academic Hospital
Full name of responsible person
Dr Mohanned M. Alsaidi
Street address
Alkadhumia, st. 60
City
Baghdad

2

Recruitment center
Name of recruitment center
Renal Diseases and Transplant Center
Full name of responsible person
Dr Qaiss H. Altaei
Street address
Medical City Complex, Babalmoadhum
City
Baghdad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Dean, College of Pharmacy, University of Baghdad
Full name of responsible person
Alaa A. Abdulrasool
Street address
Babalmoadhum 14026
City
Baghdad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Dean, College of Pharmacy, University of Baghdad
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
College of Pharmacy-University of Baghdad; College of Pharmacy-University of Toledo
Full name of responsible person
Sarmed H. Kathem
Position
Faculty
Other areas of specialty/work
Street address
Babalmoadhum 14026
City
Baghdad
Province
Baghdad
Postal code
Phone
009647901552609
Fax
Email
sarmed.kathem11@utoledo.edu
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of Pharmacy and Medicine, University of Toledo
Full name of responsible person
Surya M. Nauli
Position
Faculty, associate professor
Other areas of specialty/work
Street address
3000 Arlington ave
City
Toledo
Province
Ohio
Postal code
43614
Phone
001419383-1921
Fax
Email
surya.nauli@utoledo.edu
Web page address

Person responsible for updating data

Contact
Name of organization / entity
College of Pharmacy-University of Baghdad; College of Pharmacy-University of Toledo
Full name of responsible person
Sarmed H. Kathem
Position
Other areas of specialty/work
Street address
Babalmoadhum 14026
City
Baghdad
Province
Baghdad
Postal code
Phone
009647901552609
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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