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Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.

Primary Purpose

Diabetes Mellitus, Hypertension

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

DMSA scan

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• Patients with diabetes (type2), weather controlled or not.
- Patients with essential hypertension.
- Patients with diabetes & hypertension.
- Within normal renal function (urea & creatinine).
- Control cases may be normal individuals (apparently healthy) like donors for renal transplant.

Exclusion Criteria:

• Patients with abnormal renal function.
- Patients with diseases known to affect kidney function rather diabetes & hypertension e.g. SLE, heart failure or liver cell failure.

Sites / Locations

Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Diabetic

Hypertensive

Diabetic & Hypertensive

Arm Description

control will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

diabetic cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

hypertesive cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

Diabetic & Hypertensive cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

Outcomes

Primary Outcome Measures

Renal Counts

Quantitative Tc99m DMSA renal scan using SPECT technique will be used to measure renal function.

Secondary Outcome Measures

Full Information

NCT ID

NCT03123237

First Posted

April 15, 2017

Last Updated

April 20, 2017

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03123237

Brief Title

Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.

Official Title

Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (Actual)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

the investigators explore the possible role of DMSA to detect renal affection in diabetic &/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control & diabetic &/or hypertensive patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Hypertension

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

control will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

Arm Title

Diabetic

Arm Type

Active Comparator

Arm Description

diabetic cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

Arm Title

Hypertensive

Arm Type

Active Comparator

Arm Description

hypertesive cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

Arm Title

Diabetic & Hypertensive

Arm Type

Active Comparator

Arm Description

Diabetic & Hypertensive cases will be subjected to: • Quantitative Tc99m DMSA renal scan using SPECT technique.

Intervention Type

Diagnostic Test

Intervention Name(s)

DMSA scan

Intervention Description

We explore the possible role of DMSA to detect renal affection in diabetic &/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control & diabetic &/or hypertensive patients.

Primary Outcome Measure Information:

Title

Renal Counts

Description

Quantitative Tc99m DMSA renal scan using SPECT technique will be used to measure renal function.

Time Frame

2-4 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Patients with diabetes (type2), weather controlled or not. Patients with essential hypertension. Patients with diabetes & hypertension. Within normal renal function (urea & creatinine). Control cases may be normal individuals (apparently healthy) like donors for renal transplant. Exclusion Criteria: • Patients with abnormal renal function. Patients with diseases known to affect kidney function rather diabetes & hypertension e.g. SLE, heart failure or liver cell failure.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heba Askar, MsC

Phone

+201003040898

hebaaskar@aun.edu.eg

Facility Information:

Facility Name

Assiut university

City

Assiut

Country

Egypt

Individual Site Status

Recruiting

12. IPD Sharing Statement

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Quantitative Renal Uptake Using TC99m DMSA in Hypertensive &/or Diabetic Patients.

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