NCT03137316

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
437

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

April 28, 2017

Last Update Submit

May 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • intact parathyroid level

    intact parathyroid level

    within 1 hour from attending in the clinic

Interventions

obtain intact parathyroid hormone level from patients records.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \[1\] 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryDiabetic Nephropathies

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes Mellitus

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Internal Medidicne Department- Faculty of Medicine

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 2, 2017

Study Start

January 1, 2014

Primary Completion

February 28, 2017

Study Completion

March 1, 2017

Last Updated

May 2, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share