Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01521910
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Peter Rossing, Steno Diabetes Center Copenhagen

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus With Diabetic Nephropathy Dietary Supplement: low protein diet Dietary Supplement: normal protein diet Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy
Study Start Date : April 1995
Actual Primary Completion Date : June 2000
Actual Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Cumulative incidence of ESRD requiring dialysis or transplantation, and death [ Time Frame: 4 years ]

    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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01521910

Layout table for location information
Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Layout table for investigator information
Principal Investigator: Henrik P Hansen, MD Steno Diabetes Center Copenhagen

Layout table for additonal information
Responsible Party: Peter Rossing, Chief physician and Director of Research, Steno Diabetes Center Copenhagen Identifier: NCT01521910     History of Changes
Other Study ID Numbers: Low Protein Diet
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012
Keywords provided by Peter Rossing, Steno Diabetes Center Copenhagen:
protein restriction
diabetic nephropathy
type 1 diabetes
progressive renal disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Diabetes Complications