Diabetic Autonomic Neuropathy and Left Ventricular Function

NCT05713396 | Completed Phase 4

• 1 other identifier: 72405
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To investigate the effect of Quinapril (Q) or Losartan (L) or their combination on definite Diabetic Autonomic Neuropathy (DAN) and left ventricular systolic and diastolic function (LVF) over a period of 4 years. Patients-methods: Fifty-nine patients with definite DAN \[2 or more of the 4 Cardiovascular Reflex Tests (CRTs) were abnormal\] were studied for 4 years. Patients were randomly allocated in 3 groups receiving A, 20 mg Q, B, 100 mg L and C, 20 mg Q +100 mg L respectively. CRTs analyzed with Mean Circular Resultant (MCR), Valsalva index, 30:15 ratio and postural hypotension. LV function was investigated with radionuclide ventriculography (RNV) at rest. Ejection fraction was used to assess LV systolic function, while peak filling rate, first third filling fraction, and atrial contribution to ventricular filling were used to investigate LV diastolic function. CRTs and RNV were performed at baseline and after 4 years.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• MCR

  Mean Circular Resultant

  4 years

• AV

  Atrial contribution to ventricular filling

  4 years

Secondary Outcomes (10)

• E/I Index

  4 years

• SD

  4 years

• Valsalva Index

  4 years

• 30:15 Index

  4 years

• Postural hypotension

  4 years

Study Arms (3)

Quinapril (Q)

EXPERIMENTAL

Patients receiving Quinapril

Drug: Quinapril

Losartan (L)

EXPERIMENTAL

Patients receiving Losartan

Drug: Losartan

Quinapril + Losartan (Q+L)

EXPERIMENTAL

Patients receiving both Quinapril and Losartan

Drug: Quinapril + Losartan

Interventions

Quinapril DRUG

Per os

Quinapril (Q)

Losartan DRUG

Per os

Losartan (L)

Quinapril + Losartan DRUG

Per os

Quinapril + Losartan (Q+L)

Eligibility Criteria

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

You may qualify if:

• \>18 years old
• Diabetes mellitus
• Diabetic autonomic neuropathy

You may not qualify if:

• Coronary artery disease
• Arterial hypertension
• Heart failure with reduced ejection fraction LVEF\<40%
• Any contraindication to undergo radionuclide ventriculography

Sponsors & Collaborators

• AHEPA University Hospital: lead

Study Sites (1)

Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital

Thessaloniki, 54636, Greece

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Quinapril; Losartan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles

Study Officials

• Triantafillos Didangelos, Professor

  AHEPA University Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: January 1, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)