The Role of Insulin Resistance in Patients With Heart Failure and Type 2 Diabetes

NCT02559128 | Unknown DMC

• 1 other identifier: G 15-06-02
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this cross-sectional comparative 2x2 trial study is to compare the degree of insulin resistance, myocardial function and selected metabolic parameters and to explore the pathophysiological mechanisms by which insulin resistance is implicated in development of chronic heart failure (HF) in patients with type 2 diabetes and prediabetes (T2D). Investigators hypothesize that patients with heart failure will be insulin-resistant and will display metabolic abnormalities as patients with diabetes.

Conditions

Insulin Resistance; Chronic Heart Failure

Keywords

Insulin Resistance; Chronic Heart Failure; Type 2 Diabetes; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (3)

• Insulin sensitivity

  Difference in glucose disposal rate and metabolic clearance rate of glucose measured by hyperinsulinemic euglycemic clamp

  At baseline

• Heart function

  Difference in left ventricular ejection fraction (LV EF), diastolic function (E/E´, left atrial volume) and ventriculi-vascular coupling measured by non-invasive estimation of end-systolic left ventricular (Ees) and arterial elastance (Ea) by single beat method measured by ECHO

  At baseline

• Exercise capacity

  Difference in peak oxygen consumption (peak VO2) and chronotropy index measured by symptom-limited bicycle spiroergometry

  At baseline

Secondary Outcomes (2)

• Gut microbiota spectrum in stool and gut microbe generated trimethylamine N-oxide (TMAO) in plasma

  At baseline

• Endothelial function

  Change in digital pulse amplitude tonometry from the basal state before the clamp and at the end f the measurement

Study Arms (4)

HF+T2D+

40 patients with chronic HF and type 2 diabetes or prediabetes without previous pharmacological treatment

HF+T2D-

20 subjects with HF without T2D or prediabetes

HF-T2D+

20 subjects with T2D or prediabetes alone

HF-T2D-

20 healthy control volunteers

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 subjects in total, divided into four groups will be included: 40 patients with type 2 diabetes or prediabetes and chronic heart failure (HF+T2D+), 20 subjects with HF without T2D (HF+T2D-), 20 subjects with T2D alone (HF-T2D+) and 20 healthy control volunteers (HF-T2D-).

You may qualify if:

• A. For group HF+T2D+
• Chronic heart failure will be defined by the following criteria (all must be included):
• diagnosis of HF known for at least 6 months
• medical history of hospitalization for cardiac decompensation with need for parenteral therapy for congestion - X-ray findings or swelling of lower extremities
• stable drug therapy at least 1 month
• treatment with diuretics (thiazide or furosemide)
• left ventricular ejection fraction (LVEF) below 50%
• The presence of diabetes/prediabetes will be defined by:
• diagnosis and treatment of type 2 diabetes in the medical history
• or estimated screening blood sample: values of HbA1c (according to IFCC) ≥39 mmol/mol for prediabetes, ≥48 for diabetes and fasting plasma glucose level ≥5.6 mmol/l for prediabetes and ≥7 mmol/l for diabetes or ≥7.8 mmol/l for prediabetes and ≥11.1 mmol/l for diabetes according to oral glucose tolerance test (oGTT).
• treatment of diabetes - by diet only
• women and men aged 40-70 years
• body mass index (kg/m2) in the range of 20-35
• the range of HbA1c between 40-65 mmol/mol (IFCC)
• signed informed consent

You may not qualify if:

• metabolic disease, including: 1 type diabetes, decompensated thyreopathy (Note: patients with hypothyroidism and stable substitution (the last 3 months) of normal thyrotropic-stimulating hormone levels may participate in the study)
• pregnancy (positive human chorionic gonadotropin test), breast feeding, trying to become pregnant
• clinically significant anemia with hemoglobin below 100 g/l
• renal insufficiency with estimated glomerular filtration under 0.7 ml/s
• atrial fibrillation
• alcoholism or drug use
• the presence of other medical condition, which occurs during physical examination, laboratory tests, ECG, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Diabetes Center, Institute of Clinical and Experimental Medicine

Prague, Prague 4, 14021, Czechia

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Terezie Pelikánová, Prof., MD

  Diabetes Center, Institute of Clinical and Experimental Medicine, Prague, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Veleba, MD

CONTACT

+420 261 364 100; jiri.veleba@medicon.cz

Terezie Pelikánová, Prof., MD

CONTACT

+420 261 364 100; terezie.pelikanova@medicon.cz

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Terezie Pelikánová, MD.,PhD.

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 24, 2015
• Study Start: December 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

CZ (1)