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

NCT ID: NCT03216564

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2019-05-10

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.

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.

Conditions

Diabetic Nephropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Calcitriol

Intervention Type: DRUG

Active vitamin D (Calcitriol) 0.25 micrograms

Usual Care

Participants are treated with ACEI/ARB alone for 26 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Calcitriol

Active vitamin D (Calcitriol) 0.25 micrograms

Intervention Type: DRUG

Other Intervention Names

Active Vitamin D

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Cornell Medical College in Qatar

OTHER

Sponsor Role: collaborator

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Asim, MB BS

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Hamad Medical Corporation

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Shahrad Taheri, MB BS PhD

Role: CONTACT

szt2004@qatar-med.cornell.edu

0097444928998

Muhammad Asim, MB BS

Role: CONTACT

Masim@hamad.qa

0097455838342

Facility Contacts

Muhammad Asim, MB BS

Role: primary

Masim@hamad.qa

0097455838342

References

Taheri S, Asim M, Al Malki H, Fituri O, Suthanthiran M, August P; IDEAL-2 Study Team. Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial. Trials. 2018 Apr 17;19(1):230. doi: 10.1186/s13063-018-2616-5.

Reference Type: DERIVED

PMID: 29665833 (View on PubMed)

Other Identifiers

1400039

Identifier Type: OTHER

Identifier Source: secondary_id

16235/16

Identifier Type: -

Identifier Source: org_study_id