The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes

NCT00337298 | Completed

• 1 other identifier: Jmehl01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect of two antihypertensive drugs on retinal vessel diameter in young type 1 diabetics. The retinal vessel analyzer (RVA) was used to investigate how the drugs affected vessel diameter, when the subjects were exposed to an increase in blood pressure, induced by isometric muscle contraction and when they were stimulated by flickering light.

Conditions

Type 1 Diabetes; Diabetic Retinopathy; Eye Diseases; Diabetes Complications

Keywords

Diabetes; Retinopathy; Blood Pressure; Amlodipine; Lisinopril

Outcome Measures

Primary Outcomes (1)

• Vessel diameter changes in arbitrary units as measured with the Retinal Vessel Analyzer

  120,240,360,480,600,720 and at 840secs

Secondary Outcomes (2)

• Blood pressure (mmHG)

  120,240,360,600,720,840 secs

• 24 hour ambulatory blood pressure (mmHg)

  24 hours

Study Arms (1)

1

EXPERIMENTAL

Crossover design. Arm is same all the way

Drug: Amlodipine; Drug: Lisinopril

Interventions

Amlodipine DRUG

1 (5mg) tablet daily, given 14 days totally before measure of outcome.

1

Lisinopril DRUG

Lisinopril 10 mg given daily for 14 days and then outcome was measured.

1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes
• years of age
• Simplex retinopathy at last screening (Less than 10 retinal haemorrhages at the nearest ordinary screening examination)
• normotensive (BP not above 160 mmHg systolic or 100 mmHg diastolic)

You may not qualify if:

• Pregnancy
• Systolic Bloodpressure above 160 mmHg
• Diastolic bloodpressure above 100 mmHg
• Retinopathy grade higher than simplex retinopathy
• Prior retinal laser photocoagulation

Sponsors & Collaborators

• University of Aarhus: lead
• Velux Fonden: collaborator

Study Sites (1)

Aarhus university hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Retinopathy; Eye Diseases; Diabetes Complications; Diabetes Mellitus; Retinal Diseases

Interventions

Amlodipine; Lisinopril

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Toke Bek, MD, PhD

  Aarhus university hospital, Dep. of ophthalmology

  PRINCIPAL INVESTIGATOR

• Per L Poulsen, MD, PhD

  Aarhus University hospital, Dep. of endocrinology (M)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 15, 2006
• Study Start: July 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

DK (1)