Diabetic NephropathyNCT00708981
Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
A study testing Multifactorial Intervention in people with Diabetic Nephropathy, run by Cook County Health at 1 site in United States.
Trial summary
The purpose of this study is to compare the progression of kidney disease in subjects with Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a general care and in subjects treated by multi-factorial intervention in the Diabetes-Renal Clinic. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Multifactorial Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant is male or female diagnosed with Type 2 Diabetes mellitus defined by the American Diabetes Association criteria and must be aged 18 to 70 years.
- The participant must have documented Advanced Diabetic Nephropathy (ADN) defined as presence of proteinuria or micro/macro-albuminuria and impaired GFR (by MDRD equation) corresponding to Chronic Kidney Disease (CKD) stages 3-4 (moderate-severe i.e. estimated GFR >15ml/min and <60ml/min).
- Presence of macroalbuminuria B. Presence of microalbuminuria if no therapy with ACE inhibitors or ARBs C. Presence of current microalbuminuria and previous documentation of macroalbuminuria D. Presence of current microalbuminuria and previous documentation of Diabetic Retinopathy or laser therapy E. If only microalbuminuria and no A, B, C or D US of kidney shows NL size.
- Minimal cognitive function for a diabetes self management
- Fasting or random Blood glucose <400mg/DL
Who cannot join
- Patients with Type 1 Diabetes Mellitus.
- Serum Creatinine > 4.0 mg/dl and/or an estimated GFR of < 15 ml/min.
- Patients on renal replacement therapy.
- Patients with Hyperkalemia (K>5.0 meq/L).
- Patients with known Renal Artery stenosis.
- Patients with known cancer, hepatic impairment, dementia or other chronic medical diseases.
Show all 12Show fewer
- Patients with severe heart failure (NYHA Class III or IV symptoms and/or LVEF <25%).
- Patients with valvular or outflow tract obstruction.
- Patients with significant disability that precludes regular attendance at clinics for follow-up.
- Patients unwilling or unable to provide informed consent.
- Pregnant or lactating women.
- Current addiction to substance or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
About this study
The purpose of this study is to compare the progression of kidney disease in subjects with Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a general care and in subjects treated by multi-factorial intervention in the Diabetes-Renal Clinic.
Read the detailed description
In this study, the overall objective is comparison of progression of renal insufficiency in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) randomized into multifactorial intervention in the Diabetes-Renal Clinic (study group) and into usual care (control group). The multifactorial intervention includes the following: 1. Blood pressure control to the goal of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using a protocol that includes therapy with ACE inhibitors, ARBs or their combination. 2. Tight glucose control using SMBG and Lantus/Apidra self-escalation regimen. 3. Use of hypolipidemic therapy to achieve targets of LDL of < 70 mg/dl, HDL > 40/50 mg/dl (males/females) [since you said that HDL is not a target because there are no meds for it I deleted HDL;] and triglycerides of less than 200 mg/dl. 4. Patient enhanced self-management provided by combined diabetes-renal education curriculum (taught by certified diabetes and renal educators). 5. Behavior and social intervention (motivational interviews and social assessment) provided as needed by social workers. 6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors. 7. Weight loss with lifestyle and diet modification.
Control Group will keep on receiving the usual treatment that they used to receive from their respective clinics and the Diabetes-Renal team would not alter their therapy or interfere in their management.
- Conditions
- Diabetic Nephropathy
- Being tested
- Multifactorial Intervention
- Keywords
- Diabetic Nephropathy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifactorial InterventionOther
Study group will receive multifactorial intervention for advanced diabetic nephropathy:
Elements of multifactorial intervention:
- BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs.
- Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen.
- Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl.
- Patient enhanced self-management provided by combined diabetes-renal education curriculum.
- Behavior and social intervention
- Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | Study group will receive multifactorial intervention for advanced diabetic nephropathy:
Elements of multifactorial intervention:
1. BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs.
2. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen.
3. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl.
4. Patient enhanced self-management provided by combined diabetes-renal education curriculum.
5. Behavior and social intervention
6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators. Receives: Other: Multifactorial Intervention |
| Control Group | No intervention | Control Group will keep on receiving the usual treatment that they used to receive from their respective clinics and the Diabetes-Renal team would not alter their therapy or interfere in their management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4)
Time to reaching End Stage Renal Disease (ESRD)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startMay 2007
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Leon Fogelfeld MD, Cook County Health
- Investigators
- Leon Fogelfeld, MD, Principal investigator, John H. Stroger, Jr. Hospital of Cook County, Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708981
- Sponsor's protocol ID
- 06-177 Metabolism IST
- Other IDs
- IRB 06-177
- Status last verified
- Aug 2024
- First submitted
- 26 Jun 2008
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
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 39171639
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Diabetes-Renal Multifactorial Intervention In Patients With Advanced Diabetic Nephropathy (ADN)
- ClinicalTrials.gov ID
- NCT00708981
- Acronym / sponsor ID
- 06-177 Metabolism IST
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetic Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Collaborators
- Sanofi
- Study start
- May 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jul 2008 (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 this study is to compare the progression of kidney disease in subjects with Diabetes mellitus type 2 and Advanced Diabetic Nephropathy treated by routine follow-up as a general care and in subjects treated by multi-factorial intervention in the Diabetes-Renal Clinic.
Detailed description
In this study, the overall objective is comparison of progression of renal insufficiency in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) randomized into multifactorial intervention in the Diabetes-Renal Clinic (study group) and into usual care (control group). The multifactorial intervention includes the following: 1. Blood pressure control to the goal of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using a protocol that includes therapy with ACE inhibitors, ARBs or their combination. 2. Tight glucose control using SMBG and Lantus/Apidra self-escalation regimen. 3. Use of hypolipidemic therapy to achieve targets of LDL of < 70 mg/dl, HDL > 40/50 mg/dl (males/females) [since you said that HDL is not a target because there are no meds for it I deleted HDL;] and triglycerides of less than 200 mg/dl. 4. Patient enhanced self-management provided by combined diabetes-renal education curriculum (taught by certified diabetes and renal educators). 5. Behavior and social intervention (motivational interviews and social assessment) provided as needed by social workers. 6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors. 7. Weight loss with lifestyle and diet modification.
Control Group will keep on receiving the usual treatment that they used to receive from their respective clinics and the Diabetes-Renal team would not alter their therapy or interfere in their management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Other: Multifactorial InterventionStudy group will receive multifactorial intervention for advanced diabetic nephropathy: Elements of multifactorial intervention: 1. BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs. 2. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen. 3. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl. 4. Patient enhanced self-management provided by combined diabetes-renal education curriculum. 5. Behavior and social intervention 6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators. |
| Control Group | No intervention | –Control Group will keep on receiving the usual treatment that they used to receive from their respective clinics and the Diabetes-Renal team would not alter their therapy or interfere in their management. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The participant is male or female diagnosed with Type 2 Diabetes mellitus defined by the American Diabetes Association criteria and must be aged 18 to 70 years.
- The participant must have documented Advanced Diabetic Nephropathy (ADN) defined as presence of proteinuria or micro/macro-albuminuria and impaired GFR (by MDRD equation) corresponding to Chronic Kidney Disease (CKD) stages 3-4 (moderate-severe i.e. estimated GFR >15ml/min and <60ml/min).
- Minimal cognitive function for a diabetes self management
- Fasting or random Blood glucose <400mg/DL
Key exclusion criteria (12 listed)
- Patients with Type 1 Diabetes Mellitus.
- Serum Creatinine > 4.0 mg/dl and/or an estimated GFR of < 15 ml/min.
- Patients on renal replacement therapy.
- Patients with Hyperkalemia (K>5.0 meq/L).
- Patients with known Renal Artery stenosis.
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 |
|---|---|---|
| Multifactorial InterventionStudy group will receive multifactorial intervention for advanced diabetic nephropathy: Elements of multifactorial intervention: 1. BP control of <130/80mmHg and renal protection with reduction of proteinuria to <0.5g/day using therapy with ACE inhibitors and/or ARBs. 2. Tight glucose control with target of HbA1C of 7% and below using SMBG and Lantus/Apidra regimen. 3. Use of hypolipidemic therapy to achieve targets of LDL < 70 mg/dl, HDL > 40/50 mg/dl (M/F)and TG < 200 mg/dl. 4. Patient enhanced self-management provided by combined diabetes-renal education curriculum. 5. Behavior and social intervention 6. Intense case management that includes close follow-up of visits, laboratory monitoring and other self-adherence behaviors carried out by clinical research coordinators. | Other | Study Group |
Primary outcome
Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4)
Time frame: 2 years
Time to reaching End Stage Renal Disease (ESRD)
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 26 Aug 2024.
- 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.
Related trials for Diabetic Nephropathy
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
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.
Leon Fogelfeld, MD principal investigator
John H. Stroger, Jr. Hospital of Cook County, Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifactorial Intervention in people with Diabetic Nephropathy, run by Cook County Health at 1 site in United States.
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 5 inclusion and 12 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 26 Aug 2024. 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 United States. 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?
Delay in development in end-stage renal failure in subjects with Advanced Diabetic Nephropathy (CKD stages 3 and 4) (time frame: 2 years). 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 NCT00708981, which also lists 1 linked publication.
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 26 Aug 2024.