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

NCT00660790 | Completed Results

• 1 other identifier: TCW 02/07
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes Mellitus, Type II

Keywords

diabetes mellitus type II, therapy non-responders

Outcome Measures

Primary Outcomes (1)

• Change of Intima Media Thickness (IMT)

  Change of IMT from Baseline to 24 months

  24 months (from Baseline Visit to Visit 24 months after Baseline)

Study Arms (1)

Patients with Type 2 Diabetes

diabetic subjects, above targets

Other: Intensified Treatment of risk factors

Interventions

Intensified Treatment of risk factors OTHER

Patients received a target oriented, intensified treatment of risk factors according to current national treatment guidelines

Patients with Type 2 Diabetes

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

120 Type-2 diabetic patients with no history of vascular events and need for therapy intensification.

You may qualify if:

• 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) \< 35 kg/m2

You may not qualify if:

• History of any vascular event except angiography
• Heart failure \> 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (2)

• Tripolt NJ, Meinitzer A, Eder M, Wascher TC, Pieber TR, Sourij H. Multifactorial risk factor intervention in patients with Type 2 diabetes improves arginine bioavailability ratios. Diabet Med. 2012 Oct;29(10):e365-8. doi: 10.1111/j.1464-5491.2012.03743.x.

  PMID: 22803961 RESULT

• Tripolt NJ, Narath SH, Eder M, Pieber TR, Wascher TC, Sourij H. Multiple risk factor intervention reduces carotid atherosclerosis in patients with type 2 diabetes. Cardiovasc Diabetol. 2014 May 23;13:95. doi: 10.1186/1475-2840-13-95.

  PMID: 24884694 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Norbert Tripolt
• Organization: Medical University of Graz

norbert.tripolt@medunigraz.at

+43 316 385

Study Officials

• Harald Sourij, MD

  Department of Internal Medicine, Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 17, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: March 19, 2021
• Results First Posted: April 7, 2020

Record last verified: 2021-02

Locations

AU (1)