Type 2 Diabetes MellitusNCT00253786
Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy
A study testing Intensive multifactorial therapy and Standard therapy in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Okayama University at 1 site in Japan.
Trial summary
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Nephropathy
- What is being tested?
- Intensive multifactorial therapy and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteJapan
- Study dates
- 11 Nov 2005to 27 Nov 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes
- Urinary albumin-to-creatinine ratio: >=300 mg/g creatinine twice in the first morning urine sample
- Serum creatinine level: =<2.5 mg/dl
- Patients aged 20-75 years
Who cannot join
- Type 1 diabetes
- Hereditary diabetes or secondary diabetes
- Non-diabetic nephropathy
- Familial hypercholesterolemia
- Secondary hypertension
- Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
Show all 14Show fewer
- Malignant tumor or life threatening disease
- History of angioedema
- Patients undergoing LDL apheresis
- Biliary system obstruction or severe liver injury
- Liver dysfunction
- Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
- Pregnant or nursing patients
- Others: patients who are not suitable for this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy
Read the detailed description
Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Nephropathy
- Being tested
- Intensive multifactorial therapy, Standard therapy
- Keywords
- diabetes, nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive multifactorial therapyOther
Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care
Standard therapyOther
Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)
| Study group | Role | What they receive |
|---|---|---|
| Intensive multifactorial therapy (Protocol A) | Experimental | Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. Receives: Other: Intensive multifactorial therapy |
| Standard therapy (Protocol A) | Active comparator | Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. Receives: Other: Standard therapy |
| Intensive multifactorial therapy (Protocol B) | Experimental | Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. Receives: Other: Intensive multifactorial therapy |
| Standard therapy (Protocol B) | Active comparator | Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A
Measured: 5 years
Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B
Measured: 5 years
Secondary outcomes (10)
GFR in Protocol A
Measured: 5 years
Cardiovascular event in Protocol A
Measured: 5 years
Progression of retinopathy in Protocol A
Measured: 5 years
Urinary albumin/creatinine ratio in Protocol A
Measured: 5 years
Proteinuria (24 h collection sample) in Protocol A
Measured: 5 years
GFR in Protocol B
Measured: 5 years
Cardiovascular event in Protocol B
Measured: 5 years
Progression of retinopathy in Protocol B
Measured: 5 years
Urinary albumin/creatinine ratio in Protocol B
Measured: 5 years
Urinary protein/creatinine ratio in Protocol B
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study start11 Nov 2005
- Primary completion27 Nov 2014
- Study completion27 Nov 2014
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 Type 2 Diabetes MellitusStudies 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
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Shikata, Okayama University
- Investigators
- Hirofumi Makino, M.D., Principal investigator, Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253786
- Sponsor's protocol ID
- DNETT-Japan
- Status last verified
- Jul 2019
- First submitted
- 10 Nov 2005
- Last updated
- 23 Jul 2019
- Results posted
- No
Publications
Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
PubMed 39171639Hodson EM, Cooper TE. Altered dietary salt intake for preventing diabetic kidney disease and its progression. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD006763. doi: 10.1002/14651858.CD006763.pub3.
PubMed 36645291
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.
- ClinicalTrials.gov ID
- NCT00253786
- Acronym / sponsor ID
- DNETT-Japan
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Nephropathy
- Keywords
- diabetes, nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- 11 Nov 2005 (actual)
- Primary completion
- 27 Nov 2014 (actual)
- Study completion
- 27 Nov 2014 (actual)
- First posted
- 15 Nov 2005 (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.
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy
Detailed description
Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intensive multifactorial therapy (Protocol A) | Experimental | Other: Intensive multifactorial therapyProtocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. |
| Standard therapy (Protocol A) | Active comparator | Other: Standard therapyProtocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. |
| Intensive multifactorial therapy (Protocol B) | Experimental | Other: Intensive multifactorial therapyProtocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. |
| Standard therapy (Protocol B) | Active comparator | Other: Standard therapyProtocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 2 diabetes
- Urinary albumin-to-creatinine ratio: >=300 mg/g creatinine twice in the first morning urine sample
- Serum creatinine level: =<2.5 mg/dl
- Patients aged 20-75 years
Key exclusion criteria (14 listed)
- Type 1 diabetes
- Hereditary diabetes or secondary diabetes
- Non-diabetic nephropathy
- Familial hypercholesterolemia
- Secondary hypertension
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 |
|---|---|---|
| Intensive multifactorial therapyBlood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care | Other | Intensive multifactorial therapy (Protocol A), Intensive multifactorial therapy (Protocol B) |
| Standard therapyBlood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy) | Other | Standard therapy (Protocol A), Standard therapy (Protocol B) |
Primary outcome
Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A
Time frame: 5 years
Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B
Time frame: 5 years
10 secondary outcomes
GFR in Protocol A
Time frame: 5 years
Cardiovascular event in Protocol A
Time frame: 5 years
Progression of retinopathy in Protocol A
Time frame: 5 years
Urinary albumin/creatinine ratio in Protocol A
Time frame: 5 years
Proteinuria (24 h collection sample) in Protocol A
Time frame: 5 years
GFR in Protocol B
Time frame: 5 years
Cardiovascular event in Protocol B
Time frame: 5 years
Progression of retinopathy in Protocol B
Time frame: 5 years
Urinary albumin/creatinine ratio in Protocol B
Time frame: 5 years
Urinary protein/creatinine ratio in Protocol B
Time frame: 5 years
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 23 Jul 2019.
- Derived from this study: PubMed 39171639Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
- Derived from this study: PubMed 36645291Hodson EM, Cooper TE. Altered dietary salt intake for preventing diabetic kidney disease and its progression. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD006763. doi: 10.1002/14651858.CD006763.pub3.
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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.
Hirofumi Makino, M.D. principal investigator
Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive multifactorial therapy and Standard therapy in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Okayama University at 1 site in Japan.
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 4 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: finished, as of the sponsor's last update on 23 Jul 2019. 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 Japan. 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?
Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A (time frame: 5 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?
On the ClinicalTrials.gov record for NCT00253786, 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 23 Jul 2019.