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An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes (IDEAL-2)

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ClinicalTrials.gov Identifier: NCT03216564
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Weill Cornell Medical College in Qatar
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief Summary:
Diabetic kidney disease (nephropathy) develops in nearly 40% of patients with type 2 diabetes mellitus. Diabetic nephropathy is caused by damage to the small 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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: Calcitriol Phase 3

Detailed Description:
The investigators propose to test the efficacy and safety of a combined regimen of calcitriol and angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) in type 2 diabetes subjects with albuminuria. In the proposed study, the bioactive form of vitamin D (calcitriol) is being used for its ability to synergize with ACEI or ARB and prevent renal disease progression. The study expands on preliminary studies demonstrating a reduction in proteinuria with vitamin D analogue treatment, in subjects with both diabetic as well as non-diabetic kidney disease.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intervention Using Vitamin D for Elevated Urinary ALbumin in Diabetes (IDEAL-2)
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : May 10, 2019
Estimated Study Completion Date : May 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Participants are treated with angiotensin converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) AND active vitamin D (Calcitriol) 0.25 micrograms orally per day for 26 weeks.
Drug: Calcitriol
Active vitamin D (Calcitriol) 0.25 micrograms
Other Name: Active Vitamin D

No Intervention: Usual Care
Participants are treated with ACEI/ARB alone for 26 weeks.



Primary Outcome Measures :
  1. Urinary albumin creatinine ratio (ACR) measured biochemically [ Time Frame: 26 weeks ]
    Urine albumin and creatinine will be measured biochemically and their ratio calculated


Secondary Outcome Measures :
  1. 24-hour urine albumin (24h UA) excretion [ Time Frame: 26 weeks ]
    24-hour urine albumin (24h UA) excretion measured biochemically

  2. Estimated glomerular filtration rate (eGFR) [ Time Frame: 26 weeks ]
    Calculated using the Modification of Diet in Renal Disease (MDRD) equation

  3. Blood pressure [ Time Frame: 26 weeks ]
    Blood pressure measured using a digital sphygmomanometer


Other Outcome Measures:
  1. Patient Reported Outcome: Quality of life [ Time Frame: 26 weeks ]
    Measured using the EQ5D questionnaire



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216564


Contacts
Contact: Shahrad Taheri, MB BS PhD 0097444928998 szt2004@qatar-med.cornell.edu
Contact: Muhammad Asim, MB BS 0097455838342 Masim@hamad.qa

Locations
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Contact: Muhammad Asim, MB BS    0097455838342    Masim@hamad.qa   
Principal Investigator: Muhammad Asim, MB BS         
Principal Investigator: Shahrad Taheri, MB BS PhD         
Principal Investigator: Phyllis August, MD         
Sponsors and Collaborators
Hamad Medical Corporation
Weill Cornell Medical College in Qatar
Investigators
Principal Investigator: Muhammad Asim, MB BS Hamad Medical Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03216564     History of Changes
Other Study ID Numbers: 16235/16
1400039 ( Other Identifier: Weill Cornell Medicine - Qatar )
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: For data, please contact investigators

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Calcitriol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents