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NCT Number: NCT01521910

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus With Diabetic Nephropathy Autoimmune Diseases Chronic Disease Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center

Gentofte Municipality, Gentofte, 2820, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low protein diet

Dietary 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.

normal protein diet

Dietary 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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Registry information

Acronym: LPD

Important dates

Study start
1995
Primary completion
2000
Study completion
2000
First posted
Jan 31, 2012
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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