Insulin ResistanceEndoPatNCT01946347
Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects
A study testing mixed meal and Acute in vivo induced hyperinsulinemia in people with Insulin Resistance and Type 2 Diabetes, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes
- What is being tested?
- mixed meal and Acute in vivo induced hyperinsulinemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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)
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Diabetes Center, Institute of Clinical and Experimental Medicine
Prague, 140 21
About this study
Official title: 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.
Read the 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
- Being tested
- mixed meal, Acute in vivo induced hyperinsulinemia
- Keywords
- Insulin Resistance, Hyperglycemia, Endothelial function, Oxidative stress
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixed mealOther
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 hyperinsulinemiaOther
Hyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes | Experimental | 30 individuals with type 2 diabetes Intervention: mixed meal, acute in vivo induced hyperinsulinemia Receives: 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 Receives: Other: mixed meal; Other: Acute in vivo induced hyperinsulinemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of endothelial function (measured by EndoPat)
at 0 and after 120 minutes during the clamp and 120 minutes after meal ingestion
Measured: 120 minutes
Secondary outcomes (3)
Changes in gastrointestinal peptides concentrations
0, 30, 60, 120, 180 minutes after meal ingestion
Measured: 180 minutes
Changes in oxidative stress markers
at 0 and after 120 minutes after meal ingestion
Measured: 120 minutes
Insulin sensitivity measured as glucose disposal during clamp
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Terezie Pelikanova, Institute for Clinical and Experimental Medicine
- Investigators
- Terezie Pelikanova, Prof, MD, Principal investigator, Diabetes Center, Institute of Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946347
- Sponsor's protocol ID
- G981
- Acronym
- EndoPat
- Status last verified
- Mar 2016
- First submitted
- 5 Sep 2013
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperinsulinemia and Postprandial Metabolic Changes on Endothelial Function in Patients With Type 2 Diabetes Versus Healthy Subjects
- ClinicalTrials.gov ID
- NCT01946347
- Acronym / sponsor ID
- EndoPat / G981
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Keywords
- Insulin Resistance, Hyperglycemia, Endothelial function, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes | Experimental | Other: mixed meal, Other: Acute in vivo induced hyperinsulinemia30 individuals with type 2 diabetes Intervention: mixed meal, acute in vivo induced hyperinsulinemia |
| Healthy subjects | Active comparator | Other: mixed meal, Other: Acute in vivo induced hyperinsulinemia30 healthy men and women with no metabolic syndrome Intervention: mixed meal, acute in vivo induced hyperinsulinemia |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mixed mealBaguette 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 | Healthy subjects, Patients with type 2 diabetes |
| Acute in vivo induced hyperinsulinemiaHyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long | Other | Healthy subjects, Patients with type 2 diabetes |
Primary outcome
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
3 secondary outcomes
Changes in gastrointestinal peptides concentrations
Time frame: 180 minutes
Changes in oxidative stress markers
Time frame: 120 minutes
Insulin sensitivity measured as glucose disposal during clamp
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terezie Pelikanova, Prof, MD principal investigator
Diabetes Center, Institute of Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mixed meal and Acute in vivo induced hyperinsulinemia in people with Insulin Resistance and Type 2 Diabetes, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of endothelial function (measured by EndoPat) (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.