Glucose in Dialysis Water in Diabetics With Chronic Renal... | NCT00438503

Studies
Glucose in Dialysis Water in Diabetics With Chronic Renal Failure

NCT00438503

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Sep 15, 2015Estimated

Enrollment

18Actual

Phase

Phase 4

Conditions

Renal Failure, Chronic
Diabetic Nephropathies

Interventions

Procedure

Countries

Denmark

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

Sep 2007

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

May 2006

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Feb 20, 2007

First Submission Date that Met QC Criteria

Feb 21, 2007

First Posted Date

Feb 22, 2007Estimated

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

Sep 14, 2015

Last Update Posted Date

Sep 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purposes are 1. to measure the effect of dialysis with glucose in dialysis water on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and 2. to analyse the relationship between the changes in blood pressure and changes in vasoactive hormones

Detailed Description

The relationship between blood pressure during dialysis treatment and vasoactive hormones are studied. This includes measurements of plasma concentration of glucose, plasma concentrations og insulin, glucagon, growth hormone, renin, angiotensin II, endothelin

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Name	Type	Description	Arm Group Labels	Other Names
Procedure	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma

Secondary Outcomes

Measure	Description	Time Frame
Relationship between changes in blood pressure and and changes in hormones

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years,
Both men and women,
Dialysis treatment for at least three month due to diabetic nephropathy

Exclusion Criteria:

Heart failure,
Lung insufficiency,
Chronic liver disease,
Malignant disease,
Nephrotic syndrome,
Lack of compliance,
Unwillingness to participate

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erling B Pedersen, Professor	Regional Hospital Holstebro	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holstebro Hospital		Holstebro		7500	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D003928	Diabetic Nephropathies
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided