Efficacy of Telmisartan and the Combination of Telmisartan and Ramipril in type1 Diabetes Patients With Nephropathy
NCT ID: NCT00738660
Last Updated: 2008-08-20
Study Results
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Basic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2007-02-28
2008-05-31
Brief Summary
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The angiotensin receptor blocker telmisartan is effective at reduction of albumin excretion rate(AER) in patients with type1 diabetes and micro or macroalbuminuria. Dual blockade with the addition of ramipril an angiotensin receptor blocker gives added efficacy for reduction of AER. ARB telmisartan gives a 24 hr BP lowering effect.
Summary:
This is an open label cross over study involving 30 patients who were initially treated with Telmisartan 80 mg for eight weeks followed by addition of Ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase.
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Detailed Description
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Methods:
Open label cross over study involving 30 patients who were initially treated with telmisartan 80 mg for eight weeks followed by addition of ramipril 10 mg for a further eight weeks. Albuminuria reduction and BP reduction with both clinic and ambulatory BP records were studied at the end of each phase Overnight urine samples of nine hours duration were collected . The volume of urine was verified by measurement in a jar with accuracy of 50ml by the study investigator on every occasion. . Albuminuria was estimated by immuno-turbidimetry Hemocue albumin system Angelholm AD, Sweden (inter assay CV 4.3% ). The albumin excretion rate(AER) at baseline evaluation was determined as the mean AER of the positive urine samples. During subsequent evaluations at the end of 8weeks and at the end of 16 weeks the mean albumin excretion rate from two successive overnight urine samples was taken as the mean .Ambulatory BP (ABP) measurement :ABP was measured using Spacelabs device 90207 Spacelabs inc. use of which is described before(14) .A uniform protocol of inflation once in every 30 min was used. Cuff was applied to the nondominant arm. Recordings were started in all patients between seven and ten AM.
Conditions
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Study Design
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CROSSOVER
TREATMENT
NONE
Study Groups
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A
single experimental arm cross over of patients, addition of Ramipril onto Telmisartan.
Telmisartan, Ramipril
80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks
Interventions
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Telmisartan, Ramipril
80 mg of telmisartan administered for 8weeks,followed by addition of ramipril 10 mg for further 8weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical history of DKA
* HbA1C \< 7.5,urine AER \>/= 20 mcg/min on two overnight urine samples
Exclusion Criteria
* Unwillingness to use contraception during time of study
* Creatinine \>3 mg/dl
* Suspected/proven non diabetic nephropathy
* Active urinary sediment
14 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Post graduaate institute of medical education and research
Principal Investigators
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sanjay k bhadada, DM
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh
Locations
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Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, India
Countries
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Other Identifiers
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START1DM
Identifier Type: -
Identifier Source: org_study_id
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