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Insulin ResistanceCARMET2NCT02559128

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

An observational study of Insulin Resistance and Chronic Heart Failure, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Resistance, Chronic Heart Failure
How many people
100 participants
Where
1 siteCzechia
Study dates
Dec 2013to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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-).

Who may be able to join

  • 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)
Show all 47Show fewer
  • 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
  • B.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)
  • LVEF below 50%
  • no history of diabetes, HbA1c <39 mmol/mol (IFCC) and fasting plasma glucose level under 5.6 mmol/l
  • women and men aged 40-70 years
  • body mass index (kg/m2) in the range of 20-35
  • signed informed consent
  • C.For group HF-T2D+
  • 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 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)
  • no history of acute or chronic heart disease
  • signed informed consent
  • D.For group HF-T2D-
  • Absence of metabolic syndrome (not more than any two of the following symptoms):
  • abdominal obesity - waist circumference in men> 102 cm, in women > 88 cm
  • diagnosis and treatment of type 2 diabetes or raised fasting plasma glucose level (FPG> 5,6 mmol/l)
  • raised blood pressure (BP): systolic BP > 130 mm Hg or diastolic BP >85 mm Hg, or treatment of previously diagnosed hypertension
  • reduced HDL cholesterol in men < 1 mmol/l, in women < 1,3 mmol/l (or treatment)
  • raised triglycerides > 1,7 mmol/l (or treatment)
  • absence of chronic or acute cardiovascular disease
  • women and men aged 40-70 years
  • body mass index (kg/m2) in the range of 20-35
  • signed informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

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

Czechia1 site, 1 recruiting

  • Diabetes Center, Institute of Clinical and Experimental Medicine

    Prague, Prague 4, 14021

    Terezie Pelikanova, Prof., MD, +420 261 364 100, terezie.pelikanova@medicon.cz

    Recruiting

Other trials in Czechia

About this study

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.

Read the detailed description

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

All examinations will be done during a short admission at Diabetes Center (CD) in Institute for Clinical and Experimental Medicine (IKEM), always under comparable circumstances. All participants will undergo standardized selection of metabolic and cardiovascular tests.

Oxidative stress markers, selected cytokines, peptides and metabolites in blood and subcutaneous adipose tissue will be analyzed. Investigators assume that this project will bring new knowledge which will contribute to discovery of the mechanisms implicated in the development of heart failure in patients with type 2 diabetes.

Keywords
Insulin Resistance, Chronic Heart Failure, Type 2 Diabetes, Endothelial Dysfunction
Medical subject headings
Insulin Resistance, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02559128
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin sensitivity

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

    Measured: At baseline

  2. 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

    Measured: At baseline

  3. Exercise capacity

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

    Measured: At baseline

Secondary outcomes (2)

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

    Measured: At baseline

  2. Endothelial function

    Change in endothelial function by acute artificial hyperinsulinemia measured by digital pulse tonometry during hyperinsulinemic euglycemic clamp

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02559128
Sponsor's protocol ID
G 15-06-02
Acronym
CARMET2
Status last verified
Aug 2018
First submitted
23 Sep 2015
Last updated
8 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Insulin Resistance and Chronic Heart Failure, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 47 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiří Veleba, MD (+420 261 364 100, jiri.veleba@medicon.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin sensitivity (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02559128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.

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