Diabetic NephropathyPhase 4DIANANCT02816762
CPAP Effect on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea
A Phase 4 study testing Continuous positive airway pressure, Pharmacological treatment and Diet in people with Diabetic Nephropathy and Sleep Apnea, run by Hospital Universitario La Paz at 6 sites in Spain.
Trial summary
Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to conventional drug treatment on the albuminuria in patients with diabetic nephropathy and obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathy, Sleep Apnea
- What is being tested?
- Continuous positive airway pressure, Pharmacological treatment and Diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesSpain
- Study dates
- Jun 2016to Dec 2020
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 to 80 years old
- Overweight or obesity (BMI ≥25 kg/m2)
- Previous diagnosis of type 2 diabetes, fulfilling at least one of the following criteria: 1) current treatment with oral antidiabetic drugs and/or insulin; 2) a fasting glucose value above 126 mg/dl on at least 2 occasions; 3) blood glucose level at 2 hours after an oral glucose tolerance test is equal to or more than 200 mg/dl; or 4) a glycated hemoglobin (HbA1c) level > 6.5 %
- Clinical diagnosis of diabetic nephropathy, with a urinary albumin/creatinine ratio >30 mg/g and an estimated glomerular filtration rate more than 20 ml/min per 1.73 m2.
- Treatment with stable doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers or anti-aldosterone agents in the last four weeks.
Who cannot join
- Non diabetic nephropathy (confirmed by biopsy).
- Dialysis for acute renal failure within the 6 previous months.
- Evidence in the clinic history of relevant bilateral stenosis of renal artery (> 75%)
- Urinary albumin/creatinine ratio higher than 3000 mg/g, at the baseline visit.
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mm Hg at the baseline visit.
- Stroke, transient ischemic attack, acute coronary syndrome, or hospitalization for heart failure worsening, within the previous 30 days.
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- Professional drivers, risk profession or respiratory failure.
- Severe daytime sleepiness (Epworth sleepiness scale >18)
- Concomitant treatment with high doses of acetylsalicylic acid (> 500 mg/day) or continuous treatment with non-steroidal anti-inflammatory drugs
- Previous treatment with CPAP
- Participation in another clinical trial within the 30 days prior to randomization.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitario General de Guadalajara
Guadalajara, 19002
Hosptial Universitario La Paz, IdiPAZ
Madrid, 28034
Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28703
About this study
Official title: Effect of Continuous Positive Airway Pressure on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea
Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to conventional drug treatment on the albuminuria in patients with diabetic nephropathy and obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP treatment on the estimated glomerular filtration rate of patients with diabetic nephropathy and OSA; determine the additional longterm CPAP effect on glycemic control, insulin resistance, lipid profile, health-related quality of life and biomarkers of cardiac function, inflammation, oxidative stress, sympathetic tone and appetite-regulating hormones in patients with diabetic nephropathy and OSA; and to identify the subgroup of patients with diabetic nephropathy and OSA in which 12 months of treatment with CPAP achieve a more pronounced reduction in albuminuria.
Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional treatment-controlled trial of 12 months of duration.
Read more
Subjects will randomize to conventional dietary and pharmacological treatment or conventional dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study subjects: Subjects 18 to 80 years with overweight or obesity and a clinical diagnosis of diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and an estimated glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or anti-aldosterone drugs in the last four weeks. Efficacy variables:
urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers (inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane], endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y] and appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires: short form (SF)-12, EuroQoL and iPAQ.
- Conditions
- Diabetic Nephropathy, Sleep Apnea
- Being tested
- Continuous positive airway pressure, Pharmacological treatment, Diet
- Keywords
- CPAP, Sleep apnea, Diabetes, Nephropathy, Albuminuria
- Medical subject headings
- Diabetic Nephropathies, Sleep Apnea Syndromes, Diabetes Mellitus, Kidney Diseases, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed).
Pharmacological treatmentDrug
Also called Conventional pharmacological treatment
Conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents.
DietOther
Conventional anti-diabetic diet recommendations
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | Diet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents plus continuous positive airway pressure (CPAP) Receives: Device: Continuous positive airway pressure; Drug: Pharmacological treatment; Other: Diet |
| Control treatment | Active comparator | Diet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents. Receives: Drug: Pharmacological treatment; Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form baseline in albuminuria levels
To compare the change in albuminuria levels between the patients allocated to CPAP group and the control group
Measured: 12 months
Secondary outcomes (13)
Change from baseline in glycated hemoglobin levels
To compare the change in glycated hemoglobin levels between the patients allocated to CPAP group and the control group
Measured: 12 months
Change form baseline in HOMA index
To compare the change in HOMA index between the patients allocated to CPAP group and the control group
Measured: 12 months
Change form baseline in QUICKI index
To compare the change in QUICKI index between the patients allocated to CPAP group and the control group
Measured: 12 months
Change from baseline in cholesterol levels
To compare the change in the levels of total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides between the patients allocated to CPAP group and the control group
Measured: 12 months
Change from baseline in the levels of C-reactive protein
To compare the change in the levels of C-reactive protein between the patients allocated to CPAP group and the control group
Measured: 12 months
Change from baseline in the health-related quality of life assessed by the SF-12 questionnaire
To compare the change in the total score and the domains of the questionnaire SF-12 between the CPAP group and the control group
Measured: 12 months
Change from baseline in the health-related quality of life assessed by the EuroQoL questionnaire
To compare the change in the total score and the domains of the questionnaire EuroQoL between the CPAP group and the control group
Measured: 12 months
Change from baseline in the daily physical activity of patients with diabetic nephropathy and OSA
To compare the change in the total score of the International Physical Activity Questionnaire (iPAQ) between the CPAP group and the control group
Measured: 12 months
Change form baseline in the plasmatic levels of biomarkers of inflammation
To compare the change in the plasmatic levels of interleukin (IL)-1beta, IL-6, IL-8 and tumor necrosis factor-alpha between the CPAP group and the control group
Measured: 12 months
Change form baseline in the plasmatic levels of 8-isoprostane
To compare the change in the plasmatic levels of 8-isoprostane between the CPAP group and the control group
Measured: 12 months
Change form baseline in the plasmatic levels of endothelin
To compare the change in the plasmatic levels of endothelin, intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) between the CPAP group and the control group
Measured: 12 months
Change form baseline in the plasmatic levels of appetite-regulating hormones
To compare the change in the plasmatic levels of leptin and adiponectin between the CPAP group and the control group
Measured: 12 months
To identify the CPAP-responder subgroup of OSA patients with diabetic nephropathy
To identify the subgroup of OSA patients with diabetic nephropathy in those the CPAP treatment achieve an albuminuria reduction >20% from baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2020
- Study completionDec 2020
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Garcia-Rio, Hospital Universitario La Paz
- Investigators
- Francisco Garcia-Rio, MD, Study chair, Hospital Universitario La Paz, IdiPAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816762
- Sponsor's protocol ID
- HULP
- Acronym
- DIANA
- Status last verified
- May 2021
- First submitted
- 31 May 2016
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zamarron E, Jaureguizar A, Garcia-Sanchez A, Diaz-Cambriles T, Alonso-Fernandez A, Lores V, Mediano O, Troncoso-Acevedo F, Cabello-Pelegrin S, Morales-Ruiz E, Ramirez-Prieto MT, Valiente-Diaz MI, Gomez-Garcia T, Casitas R, Martinez-Ceron E, Galera R, Cubillos-Zapata C, Garcia-Rio F. Continuous Positive Airway Pressure Effect on Albuminuria Progression in Patients with Obstructive Sleep Apnea and Diabetic Kidney Disease: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2023 Mar 15;207(6):757-767. doi: 10.1164/rccm.202206-1091OC.
PubMed 36342964
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02816762
- Acronym / sponsor ID
- DIANA / HULP
- Conditions
- Diabetic Nephropathy, Sleep Apnea
- Keywords
- CPAP, Sleep apnea, Diabetes, Nephropathy, Albuminuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 29 Jun 2016 (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.
Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to conventional drug treatment on the albuminuria in patients with diabetic nephropathy and obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP treatment on the estimated glomerular filtration rate of patients with diabetic nephropathy and OSA; determine the additional longterm CPAP effect on glycemic control, insulin resistance, lipid profile, health-related quality of life and biomarkers of cardiac function, inflammation, oxidative stress, sympathetic tone and appetite-regulating hormones in patients with diabetic nephropathy and OSA; and to identify the subgroup of patients with diabetic nephropathy and OSA in which 12 months of treatment with CPAP achieve a more pronounced reduction in albuminuria.
Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional treatment-controlled trial of 12 months of duration.
Subjects will randomize to conventional dietary and pharmacological treatment or conventional dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study subjects: Subjects 18 to 80 years with overweight or obesity and a clinical diagnosis of diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and an estimated glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or anti-aldosterone drugs in the last four weeks. Efficacy variables:
urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers (inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane], endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y] and appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires: short form (SF)-12, EuroQoL and iPAQ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: Continuous positive airway pressure, Drug: Pharmacological treatment, Other: DietDiet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents plus continuous positive airway pressure (CPAP) |
| Control treatment | Active comparator | Drug: Pharmacological treatment, Other: DietDiet and conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged 18 to 80 years old
- Overweight or obesity (BMI ≥25 kg/m2)
- Previous diagnosis of type 2 diabetes, fulfilling at least one of the following criteria: 1) current treatment with oral antidiabetic drugs and/or insulin; 2) a fasting glucose value above 126 mg/dl on at least 2 occasions; 3) blood glucose level at 2 hours after an oral glucose tolerance test is equal to or more than 200 mg/dl; or 4) a glycated hemoglobin (HbA1c) level > 6.5 %
- Clinical diagnosis of diabetic nephropathy, with a urinary albumin/creatinine ratio >30 mg/g and an estimated glomerular filtration rate more than 20 ml/min per 1.73 m2.
- Treatment with stable doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers or anti-aldosterone agents in the last four weeks.
Key exclusion criteria (11 listed)
- Non diabetic nephropathy (confirmed by biopsy).
- Dialysis for acute renal failure within the 6 previous months.
- Evidence in the clinic history of relevant bilateral stenosis of renal artery (> 75%)
- Urinary albumin/creatinine ratio higher than 3000 mg/g, at the baseline visit.
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mm Hg at the baseline visit.
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 |
|---|---|---|
| Continuous positive airway pressureNocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed). | Device | CPAP treatment |
| Pharmacological treatmentAlso: Conventional pharmacological treatmentConventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents. | Drug | CPAP treatment, Control treatment |
| DietConventional anti-diabetic diet recommendations | Other | CPAP treatment, Control treatment |
Primary outcome
Change form baseline in albuminuria levels
Time frame: 12 months
To compare the change in albuminuria levels between the patients allocated to CPAP group and the control group
13 secondary outcomes
Change from baseline in glycated hemoglobin levels
Time frame: 12 months
Change form baseline in HOMA index
Time frame: 12 months
Change form baseline in QUICKI index
Time frame: 12 months
Change from baseline in cholesterol levels
Time frame: 12 months
Change from baseline in the levels of C-reactive protein
Time frame: 12 months
Change from baseline in the health-related quality of life assessed by the SF-12 questionnaire
Time frame: 12 months
Change from baseline in the health-related quality of life assessed by the EuroQoL questionnaire
Time frame: 12 months
Change from baseline in the daily physical activity of patients with diabetic nephropathy and OSA
Time frame: 12 months
Change form baseline in the plasmatic levels of biomarkers of inflammation
Time frame: 12 months
Change form baseline in the plasmatic levels of 8-isoprostane
Time frame: 12 months
Change form baseline in the plasmatic levels of endothelin
Time frame: 12 months
Change form baseline in the plasmatic levels of appetite-regulating hormones
Time frame: 12 months
To identify the CPAP-responder subgroup of OSA patients with diabetic nephropathy
Time frame: 12 months
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 11 May 2021.
- Derived from this study: PubMed 36342964Zamarron E, Jaureguizar A, Garcia-Sanchez A, Diaz-Cambriles T, Alonso-Fernandez A, Lores V, Mediano O, Troncoso-Acevedo F, Cabello-Pelegrin S, Morales-Ruiz E, Ramirez-Prieto MT, Valiente-Diaz MI, Gomez-Garcia T, Casitas R, Martinez-Ceron E, Galera R, Cubillos-Zapata C, Garcia-Rio F. Continuous Positive Airway Pressure Effect on Albuminuria Progression in Patients with Obstructive Sleep Apnea and Diabetic Kidney Disease: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2023 Mar 15;207(6):757-767. doi: 10.1164/rccm.202206-1091OC.
- Individual participant dataSharing planned: No
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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.
Francisco Garcia-Rio, MD study chair
Hospital Universitario La Paz, IdiPAZ
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous positive airway pressure, Pharmacological treatment and Diet in people with Diabetic Nephropathy and Sleep Apnea, run by Hospital Universitario La Paz at 6 sites in Spain.
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 11 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change form baseline in albuminuria levels (time frame: 12 months). 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 NCT02816762, 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 11 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.