NCT00438503

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2007

First QC Date

February 20, 2007

Last Update Submit

September 14, 2015

Conditions

Renal Failure, ChronicDiabetic Nephropathies

Keywords

Hemodialysis, diabetes mellitus,Chronic renal failure, dialysis ,

Outcome Measures

Primary Outcomes (1)

  • Effect og glucose in dialysis water on blood pressure, plasma glucose and hormones in plasma

Secondary Outcomes (1)

  • Relationship between changes in blood pressure and and changes in hormones

Interventions

ProcedurePROCEDURE

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holstebro Hospital

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Kidney Failure, ChronicDiabetic NephropathiesDiabetes Mellitus

Interventions

Methods

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Erling B Pedersen, Professor

    Regional Hospital Holstebro

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

May 1, 2006

Study Completion

May 1, 2007

Last Updated

September 15, 2015

Record last verified: 2007-09

Locations

DK(1)