Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy (LPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01521910
First received: January 13, 2012
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus With Diabetic Nephropathy
Dietary Supplement: low protein diet
Dietary Supplement: normal protein diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Cumulative incidence of ESRD requiring dialysis or transplantation, and death [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    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.


  • Rate of decline of GFR [ Time Frame: 4 years ]
    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.


Enrollment: 82
Study Start Date: April 1995
Study Completion Date: June 2000
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low protein diet Dietary Supplement: low protein diet

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.

Active Comparator: Normal protein diet Dietary Supplement: normal protein diet

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.


Detailed Description:

The study was a prospective, randomized, unmasked, controlled trial carried out at the Steno Diabetes Center. With concealed randomization the patients were (in blocks of two according to the level of GFR) assigned to receive either a usual-protein diet or a low-protein diet.

After randomization an iso-caloric low-protein diet of 0.6 g/kg/day was prescribed to patients in the low-protein diet group. The usual-pro tein diet consisted of the patients' pre-study diet.

The planned duration of follow-up was four years, scheduled visits every three-months. All patients gave complete history of medication, underwent examination of weight, urinary albumin-, sodium- and urea excretion, serum albumin, serum urea, hemoglobin, hemoglobin A1c, blood pressure, serum total-cholesterol, high-density lipoprotein (HDL) cholesterol.

GFR, serum triglycerides,calcium and phosphorous, anthropometric measurements, nutritional status and smoking habits were evaluated every six months.

Dietary protein intake was estimated on the basis of three consecutive 24-hour urine samples completed before each visit, using urinary excretion of urea nitrogen.

GFR was measured by plasma clearance of 51Cr-EDTA over a 4 hour period and standardized for 1.73m2 body surface area using the same surface for each patient during the study.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • pregnancy
  • history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521910

Locations
Denmark
Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center
Investigators
Principal Investigator: Henrik P Hansen, MD Steno Diabetes Center
  More Information

No publications provided

Responsible Party: Peter Rossing, Chief physician and Director of Research, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01521910     History of Changes
Other Study ID Numbers: Low Protein Diet
Study First Received: January 13, 2012
Last Updated: January 30, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Steno Diabetes Center:
survival
protein restriction
diabetic nephropathy
type 1 diabetes
GFR
ESRD
progressive renal disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on April 17, 2014