An intervention to examine the effect of vitamin D on urine protein levels in type 2 diabetes
| ISRCTN | ISRCTN86739609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86739609 |
| ClinicalTrials.gov number | NCT03216564 |
| Secondary identifying numbers | 1400039 |
- Submission date
- 10/04/2017
- Registration date
- 07/06/2017
- Last edited
- 19/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 2 diabetes mellitus (T2DM) is a long term condition where a person is unable to control their blood sugar (glucose) levels as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes (T2DM). Diabetic nephropathy is caused by damage to the tiny blood vessels in the kidneys due to uncontrolled blood sugar levels, which mean that the kidneys become less effective at filtering urine. This is associated with albuminuria (protein in the urine). Treatment with some drugs reduces the loss of albumin through the urine and delays disease progression. There is increasing evidence that vitamin D could also be important in management of diabetic kidney disease. The aim of this study is to investigate the efficacy and safety of a combined regimen of calcitriol (active vitamin D) and established drugs for diabetic kidney disease
Who can participate?
Type 2 diabetic adults with albuminuria
What does the study involve?
Participants are randomly allocated to one of two groups. All participants are being treated with medication to control their blood pressure. Those in the first group receive this usual treatment only, and those in the second group are also treated with additional vitamin D tablets for 26 weeks. At the start of the study and then after 26 weeks, participants provide urine samples to assess the amount of protein in their urine as well as tests to assess how well they are controlling their diabetes and general health.
What are the possible benefits and risks of participating?
Participants benefit from receiving regular contact with the research team which could improve the effectiveness of their condition. The risks associated with taking part in this study are minimal as the study uses methods and approaches that are already used daily in clinical practice to care for patients with diabetic kidney disease. Also, there will be close follow-up in the clinic with specific advice to avoid any potential problems.
Where is the study run from?
Hamad Medical Corporation (Qatar)
When is the study starting and how long is it expected to run for?
April 2017 to April 2018
Who is funding the study?
Qatar National Research Fund (Qatar)
Who is the main contact?
1. Professor Shahrad Taheri (scientific)
szt2004@qatar-med.cornell.edu
2. Dr Muhammad Asim (scientific)
Contact information
Scientific
Weill Cornell Medicine - Qatar
Doha
24144
Qatar
 ORCID ID |
0000-0001-8314-1500 |
|---|---|
| Phone | +974 (0)4492 8998 |
| szt2004@qatar-med.cornell.edu |
Scientific
Hamad Medical Corporation
Doha
3050
Qatar
Study information
| Study design | Single-centre open-label randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Intervention using vitamin D for Elevated urinary ALbumin in diabetes (IDEAL-2) |
| Study acronym | IDEAL-2 |
| Study objectives | Active vitamin D (1,25-dihydroxycholecalciferol (calcitriol), added to inhibition of the renin angiotensin aldosterone system (RAAS), via angiotensin converting enzyme inhibition or angiotensin receptor blockade, results in superior reduction in urine albumin excretion in type 2 diabetes mellitus (T2DM) compared to RAAS inhibition alone. |
| Ethics approval(s) | 1. Weill Cornell Medicine, Qatar Institutional Review Board, 09/01/2017, ref: 14-00039 2. Hamad Medical Corporation, Qatar, Institutional Review Board, 23/06/2016, ref: 16235/16 |
| Health condition(s) or problem(s) studied | Diabetic nephropathy |
| Intervention | Enrolled subjects, who are clinically optimised with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), will be randomised to one of two groups. Usual Care: Participants are treated with ACEI/ARB alone for 26 weeks. Intervention Group: Participants are treated with ACEI/ARB AND active vitamin D (Calcitriol) 0.25 micrograms orally per day for 26 weeks. Participants are followed up after 26 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Calcitriol |
| Primary outcome measure | Urinary albumin creatinine ratio (ACR) measured biochemically at baseline and 26 weeks |
| Secondary outcome measures | 1. 24-hour urine albumin (24h UA) excretion is measured biochemically at baseline and 26 weeks 2. Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) equation at baseline and 26 weeks 3. Blood pressure is measured using a digital sphygmomanometer at baseline and 26 weeks Tertiary outcome measures 1. Anthropometry and body composition measures are completed using Tanita bioimpedance scales at baseline and 26 weeks 2. Diabetes control is measured biochemically using glycated haemoglobin at baseline and 26 weeks 3. Cardiovascular function is assessed by measuring arterial stiffness using the Vicorder device at baseline and 26 weeks 4. Diabetic eye disease incidence is measured using retinal photographyat baseline and 26 weeks 5. Diabetic neuropathy incidence is measured using a diabetic neuropathy questionnaire and clinical examination at baseline and 26 weeks 6. Autonomic nervous system function is measured at baseline and 26 weeks 7. Obstructive sleep apnoea incidence is measured using the apnoea-hypopnoea index at baseline and 26 weeks 8. Sleepiness is measured using the Epworth Sleepiness Scale at baseline and 26 weeks 9. Quality of life is measured using the EQ5D questionnaire at baseline and 26 weeks |
| Overall study start date | 10/05/2016 |
| Completion date | 10/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 320 |
| Key inclusion criteria | 1. Age greater than or equal to 18 years and less than 80 years 2. Diagnosis of T2DM requiring treatment with at least one oral hypoglycaemic medication or insulin 2.1. Subjects will be considered to have established T2DM if the diagnosis of diabetes has been made and the subjects were treated with insulin or an oral hypoglycaemic agent for at least 6 months after diagnosis 2.2. Subjects will be considered to have newly established T2DM if the diagnosis of diabetes was diagnosed with a fasting plasma glucose ≥ 7 mmol/L (126 mg/dL) or haemoglobin A1c is >6.5% in the past 6 months 3. Documented albuminuria defined as a presence of albuminuria on two occasions in the last six months: 3.1. Albumin ≥ 30 mg/24 hour in a 24 hour urine collection, or 3.2. Albumin ≥ 20 μg/min in a short-time urine collection, or 3.3. Albumin ≥ 30 mg/L in a spot urine sample, or 3.4. A spot-urine albumin-creatinine ration (ACR) ≥ 30 mg/g creatinine (≥ 2.5 mg/mmol creatinine in men, ≥ 3.5 mg/mmol creatinine in women) 4. Estimated glomerular filtration rate (eGFR) using the 4-variable Modification of Diet in Renal Disease (MDRD) equation of ≥ 25 mL/min/1.73 m2 |
| Key exclusion criteria | 1. If female, positive pregnancy test or planning pregnancy in the subsequent 12 months 2. Pregnant 3. Breastfeeding 4. Corrected serum calcium ≥ 2.62 mmol/L 5. Serum Potassium > 5.2 mmol/L if not on ACEI or ARB; Serum Potassium > 6.0 mmol/L if on ACEI or ARB 6. 25-hydroxyvitamin D (25-OH Vit D) > 80 ng/mL 7. PTH > 200 pg/mL 8. Poorly controlled hypertension defined as systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 110 mm Hg 9. Systolic blood pressure (SBP) ≤ 110 mm Hg 10. History of kidney stones 11. History of severe chronic disease (e.g. chronic liver disease) 12. Active malignancy 13. Recent diagnosis of acute renal failure within 3 months of screening visit 14. Likelihood of renal replacement therapy within 1 year |
| Date of first enrolment | 10/04/2017 |
| Date of final enrolment | 10/10/2018 |
Locations
Countries of recruitment
- Qatar
Study participating centre
Doha
24144
Qatar
Sponsor information
Hospital/treatment centre
Hamad General Hospital
Doha
3050
Qatar
"ROR" |
https://ror.org/02zwb6n98 |
|---|
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- صندوق قطر الوطني للبحوث, QNRF
- Location
- Qatar
Results and Publications
| Intention to publish date | 01/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of findings in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/04/2018 | Yes | No |
Editorial Notes
19/04/2018: Publication reference added.
