Prevalence of Secondary Hyperparathyroidism Among Patient... | NCT03137316

Studies
Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy

NCT03137316

Sponsor

Benha University

Status

Completed

Last Update Posted

May 2, 2017Actual

Enrollment

437Actual

Phase

Not provided

Conditions

Secondary Hyperparathyroidism
Diabetic Nephropathies

Interventions

intact parathyroid hormone level

Countries

Not provided

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

May 2017

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

Jan 1, 2014Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

Mar 1, 2017Actual

First Submitted Date

Apr 28, 2017

First Submission Date that Met QC Criteria

May 1, 2017

First Posted Date

May 2, 2017Actual

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

May 1, 2017

Last Update Posted Date

May 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Hamada imam, Lecturer in Internal Medidicne Department- Faculty of Medicine, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Name	Class
New Jeddah Clinic Hospital	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy.

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

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

437Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intact parathyroid hormone level	Diagnostic Test	obtain intact parathyroid hormone level from patients records.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intact parathyroid level	intact parathyroid level	within 1 hour from attending in the clinic

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

[1] Age was above 18 years, [2] Patient had diabetic nephropathy which was diagnosed based on the presence of urinary albumin/creatinine ratio (uACR) ≥ 30 mg/gm ± 24 hours' urinary protein measurement ≥ 300 mg/day

Exclusion Criteria:

[1] patients were already receiving cinacalcet and/or [2] patients had undergone neck surgery for parathyroidectomy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

437 diabetic patients were enrolled in this study from 864 diabetic patients who attended diabetes and nephrology outpatient clinics in our tertiary care hospital in Jeddah from Jan 2014 to Feb 2017.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006962	Hyperparathyroidism, Secondary
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D007674	Kidney Diseases

Browse Leaves

Not provided

Browse Branches

Not provided