NCT00118976

Brief Summary

The primary aim is to evaluate the anti proteinuric effect of increasing doses of the ACE inhibitor, lisinopril: 20, 40 and 60 mg daily in type 1 diabetic patients with hypertension and diabetic nephropathy. The secondary aim is to evaluate the effect on blood pressure (24 hour ambulatory blood pressure) and kidney function (glomerular filtration rate (GFR)). The tertiary aim is to evaluate differences in response to treatment according to ACE/insertion/deletion (ID)-genotypes and other genetic variants in the genes of the renin angiotensin system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 23, 2006

Status Verified

November 1, 2006

First QC Date

July 1, 2005

Last Update Submit

November 22, 2006

Conditions

Diabetes Mellitus, Type IDiabetic Nephropathy

Keywords

diabetic nephropathytype 1 diabetesalbuminuriahypertension

Outcome Measures

Primary Outcomes (1)

  • albuminuria

Secondary Outcomes (2)

  • blood pressure (24 hour ambulatory) and GFR.

  • Tertiary: differences in response to treatment in patients with different ACE/ID and other renin angiotensin system genotypes.

Interventions

LisinoprilDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes (WHO criteria)
  • Diabetic nephropathy (2 out of 3 consecutive 24 hour urinary samples with albumin excretion \> 300 mg/24hour and diabetic retinopathy in the absence of signs of other kidney or urinary tract disease) 27 or diabetic glomerulosclerosis verified by biopsy.
  • Hypertension: Blood pressure \> 135 mmHg systolic and/or 85 mm Hg diastolic repeatedly.
  • Age from 18 to 70 years.

You may not qualify if:

  • Age \< 18 years or \> 70 years.
  • Pregnancy or fertile women not using adequate anticonceptive (intrauterine device, sterilization, or oral anticonceptive)
  • Malignant hypertension.
  • Blood pressure \> 180/105 mm Hg
  • Known renal artery stenosis
  • GFR \< 30 ml/min/1.73 m²
  • Serum potassium \> 4.8 mmol/ l
  • Heart failure, myocardial infarction, unstable angina or coronary bypass operation within the previous three months.
  • Abuse of drugs or alcohol.
  • Not able to understand the written information.
  • Known intolerance to ACE inhibitors.
  • Chronic use of non steroid inflammatory drugs or aspirin (above 1 g/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

  • Schjoedt KJ, Astrup AS, Persson F, Frandsen E, Boomsma F, Rossing K, Tarnow L, Rossing P, Parving HH. Optimal dose of lisinopril for renoprotection in type 1 diabetic patients with diabetic nephropathy: a randomised crossover trial. Diabetologia. 2009 Jan;52(1):46-9. doi: 10.1007/s00125-008-1184-8. Epub 2008 Oct 31.

    PMID: 18974967DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic NephropathiesAlbuminuriaHypertension

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Hans-Henrik Parving, MD

    Steno Diabetes Center Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 12, 2005

Study Start

March 1, 2005

Study Completion

September 1, 2006

Last Updated

November 23, 2006

Record last verified: 2006-11

Locations

DK(1)