Insulin Resistance : Heart Failure

NCT00486967 | Completed DMC

• 1 other identifier: MAT001
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

Whether insulin resistance common among Chronic Heart Failure (CHF) patients in Tayside and identify factors associated with insulin resistance in CHF. We also want to identify mechanism for the impaired exercise capacity and reduced peak VO2 in CHF

Conditions

Congestive Heart Failure; Heart Failure

Keywords

Insulin resistance, heart failure, congestive heart failure,; Peak VO2, Endothelial Function, Leptin, TNF.

Outcome Measures

Primary Outcomes (1)

• Fasting Insulin Resistance Index

  Fasting insulin resistance index was assessed in a cohort of 129 consecutive CHF patients testing and peripheral endothelial function testing by reactive hyperemia peripheral arterial tonometry (RH-PAT).

  Till end of study

Study Arms (2)

Heart Failure

CHF patients were identified from inpatients as well as patients attending outpatient clinics and from the general practice in the community. Diagnosis of CHF was based on the European Society of Cardiology guidelines for CHF. All patients with stable CHF were included in the study. Inpatients with CHF who were hospitalized were also included, except patients with acutely decompensated CHF requiring intravenous therapy. CHF patients with a previous diagnosis of diabetes mellitus were excluded from the study.

Controls

A group of healthy subjects were also studied. They were recruited from the community and were clinically healthy based on history, physical examination, and blood laboratory results and were not taking any medication.

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CHF patients were identified from inpatients as well as patients attending outpatient clinics and from the general practice in the community. Diagnosis of CHF was based on the European Society of Cardiology guidelines for CHF (i.e., symptoms of CHF and objective evidence of LV systolic dysfunction). All patients with stable CHF were included in the study. Inpatients with CHF who were hospitalized were also included, except patients with acutely decompensated CHF requiring intravenous therapy. CHF patients with a previous diagnosis of diabetes mellitus were excluded from the study

You may qualify if:

• One hundred patients with Left ventricular Ejection Friction (LVEF) \<35% in NYHA class I II III or IV; aged 30-90, attending the CHF clinic will be studied
• Diagnosis of CHF will be based on medical history of exertional dyspneoa, muscle fatigue and/or fluid retention and diminished LVEF (LVEF\<35%)
• The diagnosis of ischemic heart disease will be based on documentation of previous myocardial infarction, coronary artery bypass surgery or pathologic findings on coronary angiography. Idiopathic dilated cardiomyopathy will be diagnosed in the absence of a specific etiology for left ventricular dysfunction and on the basis of normal coronary arteries
• All patients should be stable with their treatment and no change in their treatment regimen for \> 6 weeks before the study
• Patients with CHF due to coronary artery disease are more likely to have abnormalities in glucose metabolism than are patients with CHF due to idiopathic dilated cardiomyopathy. Therefore, we also plan to study a control group \[n=50\] of age and sex and BMI matched patients divided into 2 groups 25 with coronary artery disease without heart failure and 25 healthy control. These patients will be identified from the Cardiology Clinics

You may not qualify if:

• Patients with decompensated CHF with signs of congestion
• Since the objective of the study is to assess prevalence of insulin resistance in CHF and not CHF secondary to other diseases like diabetes mellitus (DM), patients suffering from DM will be excluded
• Individual found during study cognitively impaired rendering them incapable to take part

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

University of Dundee

Dundee, DD1 9SY, United Kingdom

Location

Related Publications (1)

• AlZadjali MA, Godfrey V, Khan F, Choy A, Doney AS, Wong AK, Petrie JR, Struthers AD, Lang CC. Insulin resistance is highly prevalent and is associated with reduced exercise tolerance in nondiabetic patients with heart failure. J Am Coll Cardiol. 2009 Mar 3;53(9):747-53. doi: 10.1016/j.jacc.2008.08.081.

  PMID: 19245964 DERIVED

MeSH Terms

Conditions

Heart Failure; Insulin Resistance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chim C Lang, MD, FRCP

  University of Dundee, Scotland, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2007
• First Posted: June 15, 2007
• Study Start: August 1, 2006
• Primary Completion: July 31, 2008
• Study Completion: July 31, 2008
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

GB (1)