Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects

NCT01946347 | Completed DMC

• 1 other identifier: G981
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Type 2 Diabetes

Keywords

Insulin Resistance; Hyperglycemia; Endothelial function; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Changes of endothelial function (measured by EndoPat)

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

  120 minutes

Secondary Outcomes (3)

• Changes in gastrointestinal peptides concentrations

  180 minutes

• Changes in oxidative stress markers

  120 minutes

• Insulin sensitivity measured as glucose disposal during clamp

  4 hours

Study Arms (2)

Patients with type 2 diabetes

EXPERIMENTAL

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

Other: mixed meal; Other: Acute in vivo induced hyperinsulinemia

Healthy subjects

ACTIVE COMPARATOR

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

Other: mixed meal; Other: Acute in vivo induced hyperinsulinemia

Interventions

mixed meal 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.

Healthy subjects; Patients with type 2 diabetes

Acute in vivo induced hyperinsulinemia OTHER

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

Healthy subjects; Patients with type 2 diabetes

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• \. HbA1c ≥ 42 a ≤100 mmol/mol

You may not qualify if:

• 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:
• 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)
• Diabetes or impaired glucose tolerance (HbA1c ≥40 mmol/mol and/or FPG \>5,6 mmol/l), diagnosed diabetes in first-line relatives

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Diabetes Center, Institute of Clinical and Experimental Medicine

Prague, 140 21, Czechia

Location

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2; Hyperglycemia

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Terezie Pelikanova, Prof, MD

  Diabetes Center, Institute of Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.MUDr.Terezie Pelikanova DrSc.

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

CZ (1)