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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Institute for Clinical and Experimental Medicine
Sponsor:
Information provided by (Responsible Party):
Prof. Terezie Pelikanova, Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier:
NCT01946347
First received: September 5, 2013
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Insulin Resistance
Type 2 Diabetes
Other: mixed meal
Other: Acute in vivo induced hyperinsulinemia

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Hyperinsulinemia and Postprandial Metabolic Changes on Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Institute for Clinical and Experimental Medicine:

Primary Outcome Measures:
  • Changes of endothelial function (measured by EndoPat) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    at 0 and after 120 minutes during the clamp and 120 minutes after meal ingestion


Secondary Outcome Measures:
  • Changes in gastrointestinal peptides concentrations [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
    0, 30, 60, 120, 180 minutes after meal ingestion

  • Changes in oxidative stress markers [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    at 0 and after 120 minutes after meal ingestion

  • Insulin sensitivity measured as glucose disposal during clamp [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with type 2 diabetes
20 individuals with type 2 diabetes
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
20 healthy men and women with no metabolic syndrome
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

Detailed Description:

20 patients with T2D and 20 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.
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946347

Contacts
Contact: Terezie Pelikanova Pelikanova, Prof, MD +420 261 364 100 terezie.pelikanova@medicon.cz
Contact: Lenka Belinova, MD +420 261 363 164 lenka.belinova@medicon.cz

Locations
Czech Republic
Diabetes Center, Institute of Clinical and Experimental Medicine Recruiting
Prague, Czech Republic, 140 21
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Investigators
Principal Investigator: Terezie Pelikanova, Prof, MD Diabetes Center, Institute of Clinical and Experimental Medicine
  More Information

No publications provided

Responsible Party: Prof. Terezie Pelikanova, Prof.MUDr.Terezie Pelikanova DrSc., Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT01946347     History of Changes
Other Study ID Numbers: G981
Study First Received: September 5, 2013
Last Updated: September 16, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Institute for Clinical and Experimental Medicine:
Insulin Resistance
Hyperglycemia
Endothelial function
Oxidative stress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on August 26, 2014