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

Primary Purpose

Insulin Resistance, Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

Czech Republic

Study Type

Interventional

Intervention

mixed meal

Acute in vivo induced hyperinsulinemia

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Insulin Resistance, Hyperglycemia, Endothelial function, Oxidative stress

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patients with T2D:

Inclusion criteria -

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

Type 1 diabetes mellitus
Unstable drug therapy at least 3 month before the trial
Pregnancy, breast feeding or trying to become pregnant
Alcoholism or drug use
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 -

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

Diabetes or impaired glucose tolerance (HbA1c ≥40 mmol/mol and/or FPG >5,6 mmol/l), diagnosed diabetes in first-line relatives
Pregnancy, breast feeding or trying to become pregnant
Alcoholism or drug use
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

Sites / Locations

Diabetes Center, Institute of Clinical and Experimental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with type 2 diabetes

Healthy subjects

Arm Description

30 individuals with type 2 diabetes Intervention: mixed meal, acute in vivo induced hyperinsulinemia

30 healthy men and women with no metabolic syndrome Intervention: mixed meal, acute in vivo induced hyperinsulinemia

Outcomes

Primary Outcome Measures

Changes of endothelial function (measured by EndoPat)

at 0 and after 120 minutes during the clamp and 120 minutes after meal ingestion

Secondary Outcome Measures

Changes in gastrointestinal peptides concentrations

0, 30, 60, 120, 180 minutes after meal ingestion

Changes in oxidative stress markers

at 0 and after 120 minutes after meal ingestion

Insulin sensitivity measured as glucose disposal during clamp

Full Information

NCT ID

NCT01946347

First Posted

September 5, 2013

Last Updated

March 3, 2016

Sponsor

Institute for Clinical and Experimental Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01946347

Brief Title

Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

Acronym

EndoPat

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute for Clinical and Experimental Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Type 2 Diabetes

Keywords

Insulin Resistance, Hyperglycemia, Endothelial function, Oxidative stress

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with type 2 diabetes

Arm Type

Experimental

Arm Description

30 individuals with type 2 diabetes Intervention: mixed meal, acute in vivo induced hyperinsulinemia

Arm Title

Healthy subjects

Arm Type

Active Comparator

Arm Description

30 healthy men and women with no metabolic syndrome Intervention: mixed meal, acute in vivo induced hyperinsulinemia

Intervention Type

Other

Intervention Name(s)

mixed meal

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Acute in vivo induced hyperinsulinemia

Intervention Description

Hyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long

Primary Outcome Measure Information:

Title

Changes of endothelial function (measured by EndoPat)

Description

at 0 and after 120 minutes during the clamp and 120 minutes after meal ingestion

Time Frame

120 minutes

Secondary Outcome Measure Information:

Title

Changes in gastrointestinal peptides concentrations

Description

0, 30, 60, 120, 180 minutes after meal ingestion

Time Frame

180 minutes

Title

Changes in oxidative stress markers

Description

at 0 and after 120 minutes after meal ingestion

Time Frame

120 minutes

Title

Insulin sensitivity measured as glucose disposal during clamp

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Patients with T2D: Inclusion criteria - Men and women aged 30-65 years Body Mass Index in the range of 25 - 45(kg/m2) Type 2 diabetes mellitus for at least one year Treatment of T2D: diet or oral antidiabetic agents (stable drug therapy at least 3 months before the trial The presence of metabolic syndrome - any three of the following symptoms: Abdominal obesity - waist circumference in men >102 cm, in women >88 cm Diagnosis and treatment of type 2 diabetes 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) 4. HbA1c ≥ 42 a ≤100 mmol/mol Exclusion criteria - Type 1 diabetes mellitus Unstable drug therapy at least 3 month before the trial Pregnancy, breast feeding or trying to become pregnant Alcoholism or drug use 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 - Men and women aged 30-65 years Body Mass Index 25-45 (kg/m2) 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) Exclusion criteria - Diabetes or impaired glucose tolerance (HbA1c ≥40 mmol/mol and/or FPG >5,6 mmol/l), diagnosed diabetes in first-line relatives Pregnancy, breast feeding or trying to become pregnant Alcoholism or drug use 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terezie Pelikanova, Prof, MD

Organizational Affiliation

Diabetes Center, Institute of Clinical and Experimental Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Diabetes Center, Institute of Clinical and Experimental Medicine

City

Prague

ZIP/Postal Code

140 21

Country

Czech Republic

12. IPD Sharing Statement

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Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

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