Type 1 Diabetes Mellitus With Diabetic NephropathyLPDNCT01521910
Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy
A study testing low protein diet and normal protein diet in people with Type 1 Diabetes Mellitus With Diabetic Nephropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Diabetic Nephropathy
- What is being tested?
- low protein diet and normal protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 1995to Jun 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- low protein diet, normal protein diet
- Keywords
- survival, protein restriction, diabetic nephropathy, type 1 diabetes, GFR, ESRD, progressive renal disease
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 1, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Low protein diet | Experimental | Not described Receives: Dietary Supplement: low protein diet |
| Normal protein diet | Active comparator | Not described Receives: Dietary Supplement: normal protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startApr 1995
- Primary completionJun 2000
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus With Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Henrik P Hansen, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521910
- Sponsor's protocol ID
- Low Protein Diet
- Acronym
- LPD
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2012
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Protein Restriction on Prognosis in Patients With Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01521910
- Acronym / sponsor ID
- LPD / Low Protein Diet
- Keywords
- survival, protein restriction, diabetic nephropathy, type 1 diabetes, GFR, ESRD, progressive renal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Apr 1995
- Primary completion
- Jun 2000 (actual)
- Study completion
- Jun 2000 (actual)
- First posted
- 31 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low protein diet | Experimental | Dietary Supplement: low protein diet |
| Normal protein diet | Active comparator | Dietary Supplement: normal protein diet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- pregnancy
- history of congestive heart failure or myocardial infarction or coronary bypass surgery within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low protein dietAn 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. | Dietary supplement | Low protein diet |
| normal protein dietThe 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. | Dietary supplement | Normal protein diet |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik P Hansen, MD principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low protein diet and normal protein diet in people with Type 1 Diabetes Mellitus With Diabetic Nephropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of ESRD requiring dialysis or transplantation, and death (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.