Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

NCT ID: NCT01946347

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Insulin Resistance; Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients with type 2 diabetes

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

Group Type: EXPERIMENTAL

mixed meal

Intervention Type: OTHER

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.

Acute in vivo induced hyperinsulinemia

Intervention Type: OTHER

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

Healthy subjects

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

Group Type: ACTIVE_COMPARATOR

mixed meal

Intervention Type: OTHER

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.

Acute in vivo induced hyperinsulinemia

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Acute in vivo induced hyperinsulinemia

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

Intervention Type: OTHER

Eligibility Criteria

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

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. 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:

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Terezie Pelikanova

Prof.MUDr.Terezie Pelikanova DrSc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terezie Pelikanova, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Diabetes Center, Institute of Clinical and Experimental Medicine

Locations

Diabetes Center, Institute of Clinical and Experimental Medicine

Prague, , Czechia

Countries

Czechia

Other Identifiers

G981

Identifier Type: -

Identifier Source: org_study_id