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

Type 1 Diabetes Mellitus With Diabetic Nephropathy Clinical Trial

— LPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521910
• Other study ID #: Low Protein Diet
• Status: Completed
• Phase: N/A
• First received: January 13, 2012
• Last updated: January 30, 2012
• Start date: April 1995
• Est. completion date: June 2000

Study information

• Verified date: January 2012
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2000
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetic Nephropathies
• Kidney Diseases
• Type 1 Diabetes Mellitus With Diabetic Nephropathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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