Diabetic NephropathiesLPDNCT00448526
Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
A study testing low protein diet in people with Diabetic Nephropathies, run by Kanazawa Medical University.
Trial summary
Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- low protein diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1997to Aug 2006
- 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 20 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Urinary protein excretion 1-10 g/day
- Serum Cr <2.0 mg/dl
- With diabetic retinopathy > SDR
- Normal protein intake instruction
- Patients whose consent is obtained at >20 or age =<65
Who cannot join
- Type 1 Diabetes Mellitus
- Non-diabetic nephropathy
- Urinary tract infection
- Congestive heart failure
- Unstable angina
- Myocardial infarction
Show all 14Show fewer
- Stroke
- Severe hepatopathy
- Life threatening disease such as malignant tumor
- Patients on ACE-I and or ARB treatment
- Patients on instruction of low protein diet
- BW< 80% of IBW
- Pregnant, lactating, and probably pregnant patients
- Patients judged as being inappropriate fir the subjects
About this study
Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. We here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.
- Conditions
- Diabetic Nephropathies
- Being tested
- low protein diet
- Keywords
- Low protein diet, type 2 Diabetic nephropathy, Comparing the effect of Low protein Diet on diabetic nephropathy to that of normal protein diet
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low protein dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
annual change of GFR
annual change of Ccr
annual change of 1/Cr
incidence rate of the doubling of sCr
time to the doubling of sCr
Secondary outcomes (2)
urinary albumin and protein excretion
% change of urinary albumin and protein excretion from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startDec 1997
- Study completionAug 2006
Why it stopped: Terminated: recruiting or enrolling participants has halted and will not resume because low protein diet is not feasible nor efficious.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Kanazawa Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Ryuichi Kikkawa, M.D., Study director, Shiga University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448526
- Sponsor's protocol ID
- H8-H-077
- Acronym
- LPD
- Status last verified
- Mar 2007
- First submitted
- 16 Mar 2007
- Last updated
- 19 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang S, Fang J, Li W. Protein restriction for diabetic kidney disease. Cochrane Database Syst Rev. 2023 Jan 3;1(1):CD014906. doi: 10.1002/14651858.CD014906.pub2.
PubMed 36594428Koya D, Haneda M, Inomata S, Suzuki Y, Suzuki D, Makino H, Shikata K, Murakami Y, Tomino Y, Yamada K, Araki SI, Kashiwagi A, Kikkawa R; Low-Protein Diet Study Group. Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2037-45. doi: 10.1007/s00125-009-1467-8. Epub 2009 Aug 4.
PubMed 19652945
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Protein Diet in Preventing the Progression of Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00448526
- Acronym / sponsor ID
- LPD / H8-H-077
- Conditions
- Diabetic Nephropathies
- Keywords
- Low protein diet, type 2 Diabetic nephropathy, Comparing the effect of Low protein Diet on diabetic nephropathy to that of normal protein diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: recruiting or enrolling participants has halted and will not resume because low protein diet is not feasible nor efficious.
- Lead sponsor
- Kanazawa Medical UniversityUniversity, hospital or other
- Study start
- Dec 1997
- Study completion
- Aug 2006
- First posted
- 19 Mar 2007 (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.
Diabetic nephropathy is the leading cause of chronic kidney disease all the world in spite of progress in new treatment for diabetes and anti hypertensive drugs. Additional treatments are thus needed to arrest the progression of diabetic nephropathy. Although there is insufficient evidence to suggest that a low-protein diet improves renal dysfunction, it is recommended as a mainstay of nutritional management. We here assessed the role of low protein diet in renal function as well as albuminuria in type 2 diabetic patients with nephropathy for a median of 5 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus
- Urinary protein excretion 1-10 g/day
- Serum Cr <2.0 mg/dl
- With diabetic retinopathy > SDR
- Normal protein intake instruction
Key exclusion criteria (14 listed)
- Type 1 Diabetes Mellitus
- Non-diabetic nephropathy
- Urinary tract infection
- Congestive heart failure
- Unstable angina
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 diet | Behavioural | – |
Primary outcome
annual change of GFR
annual change of Ccr
annual change of 1/Cr
incidence rate of the doubling of sCr
time to the doubling of sCr
2 secondary outcomes
urinary albumin and protein excretion
% change of urinary albumin and protein excretion from baseline
Results and safety
The study was stopped early (reason given: Terminated: recruiting or enrolling participants has halted and will not resume because low protein diet is not feasible nor efficious.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2007.
- Derived from this study: PubMed 36594428Jiang S, Fang J, Li W. Protein restriction for diabetic kidney disease. Cochrane Database Syst Rev. 2023 Jan 3;1(1):CD014906. doi: 10.1002/14651858.CD014906.pub2.
- Derived from this study: PubMed 19652945Koya D, Haneda M, Inomata S, Suzuki Y, Suzuki D, Makino H, Shikata K, Murakami Y, Tomino Y, Yamada K, Araki SI, Kashiwagi A, Kikkawa R; Low-Protein Diet Study Group. Long-term effect of modification of dietary protein intake on the progression of diabetic nephropathy: a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2037-45. doi: 10.1007/s00125-009-1467-8. Epub 2009 Aug 4.
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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.
Ryuichi Kikkawa, M.D. study director
Shiga University of Medical Science
Questions about this trial
What is this clinical trial studying?
A study testing low protein diet in people with Diabetic Nephropathies, run by Kanazawa Medical University.
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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 19 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Terminated: recruiting or enrolling participants has halted and will not resume because low protein diet is not feasible nor efficious.). Results are not available in the source record.
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?
annual change of GFR. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448526, which also lists 2 linked publications.
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 19 Mar 2007.