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Efficacy of Administration of ACE-Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03031834
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Konstantinos Tziomalos, Aristotle University Of Thessaloniki

Brief Summary:
Patients with diabetes mellitus and definite autonomic and peripheral neuropathy were randomized to receive quinapril or no treatment for 2 years.

Condition or disease Intervention/treatment Phase
Diabetic Autonomic Neuropathy Drug: Quinapril Phase 4

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Study Type : Interventional  (Clinical Trial)
Official Title: Efficacy of Administration of Angiotensin Converting Enzyme Inhibition on Autonomic and Peripheral Neuropathy in Patients With Diabetes Mellitus
Study Start Date : January 1999
Actual Primary Completion Date : May 2001

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in R-R variation during deep breathing [ Time Frame: 2 years ]
  2. Changes in response to Valsalva maneuver [ Time Frame: 2 years ]
  3. Changes in 30:15 ratio [ Time Frame: 2 years ]
  4. Changes in blood pressure response to standing [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Diabetes mellitus with both autonomic and peripheral neuropathy

Exclusion Criteria:

  • Hypertension, coronary heart disease

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Responsible Party: Konstantinos Tziomalos, Assistant Professor of Internal Medicine, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03031834     History of Changes
Other Study ID Numbers: AristotleUMEDSCH095
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Quinapril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents