NCT03123237

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

April 15, 2017

Last Update Submit

April 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Renal Counts

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

    2-4 hours

Study Arms (4)

Control

PLACEBO COMPARATOR

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

Diagnostic Test: DMSA scan

Diabetic

ACTIVE COMPARATOR

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

Diagnostic Test: DMSA scan

Hypertensive

ACTIVE COMPARATOR

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

Diagnostic Test: DMSA scan

Diabetic & Hypertensive

ACTIVE COMPARATOR

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

Diagnostic Test: DMSA scan

Interventions

DMSA scanDIAGNOSTIC_TEST

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.

ControlDiabeticDiabetic & HypertensiveHypertensive

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Heba Askar, MsC

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

April 15, 2017

First Posted

April 21, 2017

Study Start

July 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations