AtherosclerosisINFORMNCT02130505
Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
A study testing OGTT in people with Atherosclerosis and Leukocyte Activation Disorder, run by Sint Franciscus Gasthuis.
Trial summary
In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Leukocyte Activation Disorder, Type 2 Diabetes Mellitus
- What is being tested?
- OGTT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jun 2008
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent
- Aged 45-65 years
- BMI < 35 kg/m2
Who cannot join
- Emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. Subjects who are not able to understand the patient information
- Diabetes mellitus treated with oral antidiabetic medicine
- Type 1 diabetes mellitus
- Peripheral artery and/or coronary disease
- Untreated hypertension
- Alcohol use > 2 units/day
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- Aberrations in kidney, liver and thyroid function
- Use of any experimental medication within 6 months of the study
- The use of immunosuppressive drugs
About this study
In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.
Read the detailed description
Cardiovascular disease (CVD) is number one killer in the Netherlands. Insulin resistance and dyslipideima are the main causes of CVD. Recently, we have shown that there is an acute leukocyte activation after an oral glucose tolerance test (OGTT) in patients with newly-diagnosed diabets mellitus type 2 (T2DM). Leukocyte activation is an important and obligatory aspect in the process of atherosclerosis. Complement system is another important inflammatory component in atherosclerosis, which becomes activated in the postprandial phase.
In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.
- Conditions
- Atherosclerosis, Leukocyte Activation Disorder, Type 2 Diabetes Mellitus, Familial Combined Hyperlipidemia
- Being tested
- OGTT
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus, Type 2, Hyperlipidemia, Familial Combined
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTTDietary supplement
Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose
| Study group | Role | What they receive |
|---|---|---|
| T2DM | Active comparator | Patients with type 2 diabetes mellitus, defined as having met the diagnostic criteria as outlined by the World Health Organization Receives: Dietary Supplement: OGTT |
| FCH | Active comparator | Patients with familial combined hyperlipidemia, defined as familial hyperlipidemia with a dominant inheritance pattern, elevated plasma apolipoprotein (apo) B concentrations (>1.2 g/L) and elevated triglyceride (TG) levels (>1.7 mmol/L) at the time of diagnosis Receives: Dietary Supplement: OGTT |
| FH | Active comparator | Patients with familial hyperlipidemia, defined as having met the diagnostic criteria as outlined by the world Health Organization Receives: Dietary Supplement: OGTT |
| Healthy controls | Active comparator | Healthy controls Receives: Dietary Supplement: OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial change in leukocyte activation
Leukocyte activation is determined by flow cytometry, using fluorescent labelled antibodies: FITC-conjugated anti-CD66b and PE-conjugated anti-CD11b, expressed in mean fluorescence intensity in arbitrary units. The difference in postprandial response, expressed as area under the curve, between patients with T2DM, FCH and healthy controls is determined using ANOVA.
Measured: area under the curve during 2 hours
Secondary outcomes (2)
Correlation between chronic glycemia and leukocyte activation
To assess whether chronic hyperglycemia (HbA1c) correlates with postprandial leukocyte activation, correlation between HbA1c and postprandial leukocyte activation (area under the curve) will be determined for the total study group.
Measured: area under the curve during 2 hours
Correlation between acute glycemia and leukocyte activation
To assess whether acute hyperglycemia correlates with postprandial leukocyte activation, correlation between fasting glucose levels and postprandial leukocyte activation (area under the curve) will be determined for the total study group.
Measured: area under the curve during 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.A. de Vries, Sint Franciscus Gasthuis
- Investigators
- Manuel Castro Cabezas, MD, PhD, Study chair, Sint Franciscus Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130505
- Sponsor's protocol ID
- NL17100.101.07
- Acronym
- INFORM
- Status last verified
- May 2014
- First submitted
- 21 Apr 2014
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
de Vries MA, Alipour A, Klop B, van de Geijn GJ, Janssen HW, Njo TL, van der Meulen N, Rietveld AP, Liem AH, Westerman EM, de Herder WW, Cabezas MC. Glucose-dependent leukocyte activation in patients with type 2 diabetes mellitus, familial combined hyperlipidemia and healthy controls. Metabolism. 2015 Feb;64(2):213-7. doi: 10.1016/j.metabol.2014.10.011. Epub 2014 Oct 16.
PubMed 25456098
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Aspects of Glucose in Hyperlipidemia and Diabetes
- ClinicalTrials.gov ID
- NCT02130505
- Acronym / sponsor ID
- INFORM / NL17100.101.07
- Conditions
- Atherosclerosis, Leukocyte Activation Disorder, Type 2 Diabetes Mellitus, Familial Combined Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Sint Franciscus GasthuisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 May 2014 (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.
In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.
Detailed description
Cardiovascular disease (CVD) is number one killer in the Netherlands. Insulin resistance and dyslipideima are the main causes of CVD. Recently, we have shown that there is an acute leukocyte activation after an oral glucose tolerance test (OGTT) in patients with newly-diagnosed diabets mellitus type 2 (T2DM). Leukocyte activation is an important and obligatory aspect in the process of atherosclerosis. Complement system is another important inflammatory component in atherosclerosis, which becomes activated in the postprandial phase.
In this study, we will investigate both inflammatory systems in healthy volunteers and patients with T2DM on insulin therapy and hyperlipidemia (both familial hyperlipidemia (FH) and familial combined hyperlipidemia (FCH)) during an OGTT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T2DM | Active comparator | Dietary Supplement: OGTTPatients with type 2 diabetes mellitus, defined as having met the diagnostic criteria as outlined by the World Health Organization |
| FCH | Active comparator | Dietary Supplement: OGTTPatients with familial combined hyperlipidemia, defined as familial hyperlipidemia with a dominant inheritance pattern, elevated plasma apolipoprotein (apo) B concentrations (>1.2 g/L) and elevated triglyceride (TG) levels (>1.7 mmol/L) at the time of diagnosis |
| FH | Active comparator | Dietary Supplement: OGTTPatients with familial hyperlipidemia, defined as having met the diagnostic criteria as outlined by the world Health Organization |
| Healthy controls | Active comparator | Dietary Supplement: OGTTHealthy controls |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide written informed consent
- Aged 45-65 years
- BMI < 35 kg/m2
Key exclusion criteria (9 listed)
- Emotionally and intellectually not capable to decide about participation in the study and the consequences of participation. Subjects who are not able to understand the patient information
- Diabetes mellitus treated with oral antidiabetic medicine
- Type 1 diabetes mellitus
- Peripheral artery and/or coronary disease
- Untreated hypertension
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 |
|---|---|---|
| OGTTOral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose | Dietary supplement | FCH, FH, Healthy controls, T2DM |
Primary outcome
Postprandial change in leukocyte activation
Time frame: area under the curve during 2 hours
Leukocyte activation is determined by flow cytometry, using fluorescent labelled antibodies: FITC-conjugated anti-CD66b and PE-conjugated anti-CD11b, expressed in mean fluorescence intensity in arbitrary units. The difference in postprandial response, expressed as area under the curve, between patients with T2DM, FCH and healthy controls is determined using ANOVA.
2 secondary outcomes
Correlation between chronic glycemia and leukocyte activation
Time frame: area under the curve during 2 hours
Correlation between acute glycemia and leukocyte activation
Time frame: area under the curve during 2 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 5 May 2014.
- Derived from this study: PubMed 25456098de Vries MA, Alipour A, Klop B, van de Geijn GJ, Janssen HW, Njo TL, van der Meulen N, Rietveld AP, Liem AH, Westerman EM, de Herder WW, Cabezas MC. Glucose-dependent leukocyte activation in patients with type 2 diabetes mellitus, familial combined hyperlipidemia and healthy controls. Metabolism. 2015 Feb;64(2):213-7. doi: 10.1016/j.metabol.2014.10.011. Epub 2014 Oct 16.
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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.
Manuel Castro Cabezas, MD, PhD study chair
Sint Franciscus Gasthuis
Questions about this trial
What is this clinical trial studying?
A study testing OGTT in people with Atherosclerosis and Leukocyte Activation Disorder, run by Sint Franciscus Gasthuis.
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 3 inclusion and 9 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 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Postprandial change in leukocyte activation (time frame: area under the curve during 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02130505, which also lists 1 linked publication.
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 5 May 2014.