Diabetic nephropathy Nutritional, Metabolic, Endocrine Diabetic nephropathy
Conditions
Interventions
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: Part
Sponsors
Hamad Medical Corporation
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary albumin creatinine ratio (ACR) measured biochemically at baseline and 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
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Outcome results
None listed