N/A Completed N=97

Multifactorial Treatment of Cardiovascular Risk in Diabetic Patients: Identification of Treatment Non-Responders

Diabetes Mellitus, Type II

Source: ClinicalTrials.gov NCT00660790 ↗

Enrolled (actual)

Serious AEs

18.6%

Results posted

Apr 2020

Primary outcomePrimary: Change of Intima Media Thickness (IMT) — -0.023 mm — p=0.021

Summary

The aim of the study is to develop a model that allows early identification of type-2 diabetic patients who will face progressive atherosclerosis despite intensive, multifactorial, target oriented treatment

Outcome Measures

Outcome	Result	p-value
PRIMARY Change of Intima Media Thickness (IMT)	-0.023	0.021 sig

Eligibility Criteria

Inclusion Criteria

Diabetes mellitus type-2
Indication to multifactorial risk intervention not in treatment target by means of two out of the following criteria:
Low Density Lipoprotein (LDL)-cholesterol > 120 mg/dl treated or untreated
Blood pressure: systolic >140 mmHg or diastolic >90 mmHg (office reading, treated or untreated)
(Glycated Hemoglobin) HbA1c > 7.5 % treated or untreated
Signed informed consent
Age 45 to 75 years
Body Mass Index (BMI) New York Heart Association (NYHA) II
Serum Creatinine > 3.0 mg/dl
Triglycerides > 400 mg/dl
Aspartat-Aminotransferase (AST) / Alanin aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)
Major psychiatric disorder

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00660790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.