Effect of Renin-angiotensin System Blockers on Glomerular Filtration Rate in Patients With Hypertension, Type 2 Diabetes With Normoalbuminuria

NCT01500590 | Unknown Phase 4

• 1 other identifier: 001
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is the leading cause of chronic kidney disease in developed countries. About 30-40% of patients with type 1 and type 2 diabetes mellitus will develop diabetic nephropathy. Microalbuminuria is often used as an early predictor of diabetic nephropathy. Many studies already demonstrated the renoprotective effect of Renin-angiotensin-system (RAS) blockers in patients with varying degree of albuminuria, few studies focus on studying the decline in glomerular filtration rate (GFR) among patients with normoalbuminuria. However a substantial number of diabetic patients exist with sub-normal GFR without microalbumin excretion. From literature, diabetes mellitus will have faster decline in GFR but the investigators do not know whether such decline can be slowed down by the use of RAS blockers as compared with other anti-hypertensive drugs. This Study investigate the effect of early treatment with RAS blockers on the decline rate of GFR in diabetic patients with normoalbuminuria.

Conditions

Diabetes; Hypertensive Disease

Keywords

Diabetes; hypertensive; without albuminuria

Outcome Measures

Primary Outcomes (1)

• change of estimated GFR calculated by MDRD equation and onset of microalbuminuria

  Diabetes mellitus patients assigned to have RAS blockers have slower decline in GFR and delay in onset of microalbuminuria compared with those using other anti-hypertensive drugs. We measure the value of eGFR at baseline and every 6 months period in both control group and intervention group. The eGFR is calculated by MDRD equation. GFR = 186 x {serum creatinine (umol/l) /88.4}-1.154 x (age) -0.203 x ( 0.742 if female) We than calculate the difference of eGFR value every 6 month from the baseline. We would like to compare this difference in both groups.

  every 3 months

Study Arms (2)

renin-angiotensin system blockers

EXPERIMENTAL

Those eligible patients will be randomized into 2 groups. One group use renin-angiotensin systems (RAS) blockers to control their blood pressure, the other group will use other types of anti-hypertensive agents other than RAS blockers

Drug: Renin-angiotensin system blockers

non-renin angiotensin system blockers

ACTIVE COMPARATOR

These includes norvasc adalat retard natrilix betaloc aldomet amlodipine 2.5 to 10 mg once daily nifedipine retard 20mg once daily to 40mg twice daily indapamide 2.5mg once daily metoprolol 25mg to 100mg daily methyldopa 125 mg once daily to 500mg twice daily

Drug: non-renin angiotensin system blockers

Interventions

Renin-angiotensin system blockers DRUG

ramipril 2.5mg to 10mg once daily if patient experience cough, we will use irbesartan 150 mg to 300mg once daily

Also known as: ramipril, irbesartan

renin-angiotensin system blockers

non-renin angiotensin system blockers DRUG

amlodipine 2.5 to 10 mg once daily nifedipine retard 20mg to 40mg twice daily indapamide 2.5mg once daily metoprolol 25mg to 100mg daily methyldopa 125 mg to 500mg twice daily

Also known as: norvasc, adalat retard, betaloc, natrilix or aldomet

non-renin angiotensin system blockers

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=35 - 80 years old who is capable to give consent
• Chinese
• Either (i) Type 2 diabetes mellitus (DM) diagnosed according to ADA guideline or (ii) Hypertension defined as systolic blood pressure \>140 or diastolic \>90 mmHg or taking anti-hypertensive medication to attain blood pressure under these level or having (i) and (ii)
• Estimated GFR (eGFR) (based on blood test taken 3 months prior to the date of consent) 60 - 89 ml/min/1.73m2 calculated by the abbreviated 4 variable Modification of Diet in Renal Disease (MDRD) study equation and no other identified causes of renal insufficiency.
• Normoalbuminuria determined by urine albumin to creatinine ratio (based on urine test taken 3 months prior to the date of consent) \<2.5 mg/mmol for men or \<3.5 mg/mmol for women in first morning void urine sample.

You may not qualify if:

• Patients currently on ACEI or ARB as their anti-hypertensive medication
• Pregnancy
• Type 1 diabetes
• Non-diabetic renal disease including renal artery stenosis
• Secondary hypertension
• History of symptomatic heart failure
• History of myocardial infarction within 6 months
• Specific indication for or contraindication to use ACEI or ARB
• History of allergy to ACEI or ARB

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Hospital Authority, HKEC, FM&PHC

Hong Kong, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Interventions

Ramipril; Irbesartan; Amlodipine; Metoprolol; Indapamide; Methyldopa

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Polycyclic Compounds; Dihydropyridines; Pyridines; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Sulfonamides; Amides; Sulfones; Sulfur Compounds; Indoles; Dihydroxyphenylalanine; Catecholamines; Catechols; Phenols; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• Wai Sing, Daniel CHU, M.B.,B.S.

  Hospital Authority, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 28, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

CN (1)