Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects (EndoPat)

March 3, 2016 updated by: Prof. Terezie Pelikanova, Institute for Clinical and Experimental Medicine

Effect of Hyperinsulinemia and Postprandial Metabolic Changes on Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

The aim of the study is to evaluate the effect of hyperinsulinemia and postprandial changes in plasma glucose and lipids concentrations on the endothelial function together with other metabolic parameters in patients with type 2 diabetes (T2D) and in healthy subjects.

Hypothesis:

Different changes in endothelial function to acute in vivo induced hyperinsulinemia and after the meal test will be found in patients with T2D compared to healthy subjects.

A significant relationships between insulin sensitivity, selected adipokines intramyocellular fat content, hepatic fat content and high energy phosphates in soleus muscle will be documented in both groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

30 patients with T2D and 30 healthy control subjects will be examined on an outpatient basis. The following examination will be carried out in each subject after 12 hrs fasting:

  • Hyperinsulinaemic euglycemic clamp study lasting 4 hours combined with indirect calorimetry and biopsy of subcutaneous adipose tissue and muscle aspiration biopsy
  • Meal test:Plasma glucose, immunoreactive insulin, plasma lipids, oxidative stress markers and gastrointestinal peptides measured in response to a standard meal(at times 0´,30´,60´,120´,180´)
  • At the beginning and after 120 minutes during the meal test and clamp peripheral microvascular endothelial function will be measured using EndoPat(Itamar Medical)
  • Proton and phosphorus magnetic resonance spectroscopy(MRS).
  • Dual Energy X-ray Absorptiometry(DXA) scanning to measure body composition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 140 21
        • Diabetes Center, Institute of Clinical and Experimental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Patients with T2D:

Inclusion criteria -

  1. Men and women aged 30-65 years
  2. Body Mass Index in the range of 25 - 45(kg/m2)
  3. Type 2 diabetes mellitus for at least one year
  4. Treatment of T2D: diet or oral antidiabetic agents (stable drug therapy at least 3 months before the trial

  5. The presence of metabolic syndrome - any three of the following symptoms:

    1. Abdominal obesity - waist circumference in men >102 cm, in women >88 cm
    2. Diagnosis and treatment of type 2 diabetes
    3. Raised blood pressure (BP): systolic BP > 130 mm Hg or diastolic BP >85 mm Hg, or treatment of previously diagnosed hypertension
    4. Reduced HDL cholesterol in men < 1 mmol/l, in women < 1,3 mmol/l (or treatment)
    5. Raised triglycerides > 1,7 mmol/l (or treatment)

4. HbA1c ≥ 42 a ≤100 mmol/mol

Exclusion criteria -

  1. Type 1 diabetes mellitus
  2. Unstable drug therapy at least 3 month before the trial
  3. Pregnancy, breast feeding or trying to become pregnant
  4. Alcoholism or drug use
  5. Presence of other medical condition, which occurs during physical examination, laboratory tests, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data

Healthy subjects:

Inclusion criteria -

  1. Men and women aged 30-65 years
  2. Body Mass Index 25-45 (kg/m2)

  3. Absence of metabolic syndrome - not more than any two of the following symptoms:

    1. Abdominal obesity - waist circumference in men >102 cm, in women >88 cm
    2. Diagnosis and treatment of type 2 diabetes or raised fasting plasma glucose level (FPG >5,6 mmol/l)
    3. Raised blood pressure (BP): systolic BP >130 mm Hg or diastolic BP >85 mm Hg, or treatment of previously diagnosed hypertension
    4. Reduced HDL cholesterol in men <1 mmol/l, in women <1,3 mmol/l(or treatment)
    5. Raised triglycerides > 1,7 mmol/l (or treatment)

Exclusion criteria -

  1. Diabetes or impaired glucose tolerance (HbA1c ≥40 mmol/mol and/or FPG >5,6 mmol/l), diagnosed diabetes in first-line relatives
  2. Pregnancy, breast feeding or trying to become pregnant
  3. Alcoholism or drug use
  4. Presence of other medical condition, which occurs during physical examination, laboratory tests, including pulmonary, neurological or inflammatory disease, which would be considered by the examiner to distort the consistency of data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with type 2 diabetes
30 individuals with type 2 diabetes Intervention: mixed meal, acute in vivo induced hyperinsulinemia
Other: mixed meal

Baguette Cheese Gourmet (Crocodile:

180g, energy 452.8 Kcal, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.

Other: Acute in vivo induced hyperinsulinemia
Hyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long
Active Comparator: Healthy subjects
30 healthy men and women with no metabolic syndrome Intervention: mixed meal, acute in vivo induced hyperinsulinemia
Other: mixed meal

Baguette Cheese Gourmet (Crocodile:

180g, energy 452.8 Kcal, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.

Other: Acute in vivo induced hyperinsulinemia
Hyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of endothelial function (measured by EndoPat)
Time Frame: 120 minutes
at 0 and after 120 minutes during the clamp and 120 minutes after meal ingestion
120 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in gastrointestinal peptides concentrations
Time Frame: 180 minutes
0, 30, 60, 120, 180 minutes after meal ingestion
180 minutes
Changes in oxidative stress markers
Time Frame: 120 minutes
at 0 and after 120 minutes after meal ingestion
120 minutes
Insulin sensitivity measured as glucose disposal during clamp
Time Frame: 4 hours
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute for Clinical and Experimental Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terezie Pelikanova, Prof, MD, Diabetes Center, Institute of Clinical and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G981

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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