NCT01521910

Brief Summary

The purpose of the investigators study was to determine the effect of dietary protein restriction on survival and progression to end stage renal disease (ESRD) in diabetic nephropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 1995

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1995

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
11.6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

5.2 years

First QC Date

January 13, 2012

Last Update Submit

January 30, 2012

Conditions

Type 1 Diabetes Mellitus With Diabetic Nephropathy

Keywords

survivalprotein restrictiondiabetic nephropathytype 1 diabetesGFRESRDprogressive renal disease

Outcome Measures

Primary Outcomes (2)

  • Cumulative incidence of ESRD requiring dialysis or transplantation, and death

    Cause of death was obtained from death certificate by an independent observer. Before the development of uremic symptoms, patients were referred to the department of nephrology at the University Hospital of Herlev or Rigshospitalet, when GFR deteriorated below 10 to 20 ML/min/1.73m2, where accepted criteria for initiation of dialysis and transplantation were applied on patients from both diet groups. Patients continued their scheduled visits and treatment in the study until the end of the four-year follow up. This was assesed every 3 months until the end of the 4 year follow up period.

    4 years

  • Rate of decline of GFR

    rate of decline was measured if the patient had a minimum of one year of follow up and a minimum of 3 GFR measures during the study. All measures of GFR during the study period (including baseline) were used to calculate the rate of decline(the slopes) of GFR. GFR was measured every 6 months during the 4 years of follow up.

    4 years

Study Arms (2)

Low protein diet

EXPERIMENTAL
Dietary Supplement: low protein diet

Normal protein diet

ACTIVE COMPARATOR
Dietary Supplement: normal protein diet

Interventions

low protein dietDIETARY_SUPPLEMENT

An iso-caloric low protein diet of 0.6 g/kg/day was prescribed during the whole study duration. The same dietician gave nutritional advices at least every three months during the whole study period. Patients were also seen by the same doctor during each visit for the whole study period. Supplementation of Calcium of 500mg/day. Urine albumin losses \>= 2 g/day wre replaced by increasing dietary protein on a gram-for-gram basis, only if the patient was compliant with the prescribed low-protein diet.

Low protein diet
normal protein dietDIETARY_SUPPLEMENT

The patients pre-study diet during the whole study period Patients were also seen by the same doctor during each visit for the whole study period.

Normal protein diet

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes mellitus type 1
  • duration at least 10 years
  • onset before age of 35,
  • presence of diabetic retinopathy
  • albuminuria\>=300mg/24 h in at least 2/3 sterile urine samples
  • no clinical or laboratory evidence of other kidney or urinary tract disease
  • GFR above 20mL/min/1.73M2
  • pre-study decline in GFR\>= 2 mL/min/year

You may not qualify if:

  • pregnancy
  • history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, Gentofte, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 1Kidney Failure, Chronic

Interventions

Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Henrik P Hansen, MD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician and Director of Research

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 31, 2012

Study Start

April 1, 1995

Primary Completion

June 1, 2000

Study Completion

June 1, 2000

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

DK(1)