Comparison of A New Technique of Measure of the Insulin Resistance By Scintigraphy With the Reference Technique (GLUCIMAG2)

August 25, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Comparaison d'Une Nouvelle Technique de Mesure de l'insulinorésistance Par Scintigraphie Avec la Technique de référence : Utilisation du 6-DIG Comme Marqueur du Transport du Glucose.

Insulin resistance is closely associated with apparition of type 2 diabetes mellitus; it is an independent risk factor and predicts future cardiovascular events.

Hyperinsulinemic euglycemic clamp is a validated method to assessment of insulin resistance and It is also the gold standard technique. However, the complexity and length of this technique render it unsuitable for routine clinical use.

In this study, the investigators use a new technique to provide precise, objective, fast and automated quantification of insulin resistance with camera SPECT.

They compare the results with those of the measurement of hyperinsulinemic euglycemic clamp in population with or without insulin resistance.

The proposed study is to validate this new non-invasive imaging technique for evaluation of insulin resistance in patients with or without insulin resistance with a comparison with hyperinsulinemic euglycemic clamp.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Currently, type II diabetes mellitus, has reached epidemic levels in the world. Moreover, the prediction for the year 2030 is even more alarming. Insulin resistance, characterized by a depressed cellular sensitivity to insulin in insulin-sensitive organs, is a central feature of the metabolic syndrome and a risk factor for type 2 diabetes. Its appearance may precede the diagnosis of true diabetes several years. Insulin resistance results in decreased membrane translocation of GLUT-4, whole the molecular mechanism remains unclear. Currently, there is no simple tool to measure insulin resistance. The gold standard technique remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this technique render it unsuitable for routine clinical use. Many methods or index have been proposed to assess insulin resistance in human, but none have shown enough relevance to be used in clinical use. Moreover, all these clinical measurements focus on whole-body glucose uptake, however an accurate and convenient procedure for insulin resistance measurement by organ would be interesting. Indeed there are increasingly evidences to insulin resistance as a primary etiologic factor in the development of nonischemic heart failure (HF), another growing public health problem.

Nuclear imaging provides interesting methods to measure insulin resistance using Positron Emission Tomographic (PET) tracer. Two glucose analogs [18F]2-fluoro-2-deoxy-D-glucose (FDG) and [11Cl-30methyl-n-glucose (3-OMG) have been used to evaluate noninvasively the cellular uptake of glucose using PET techniques for several organs like heart, skeletal muscle blood-brain barrier, and liver. [18F] 2-fluoro-2-deoxy-D-glucose (FDG), the most commonly used to study glucose metabolism in humans, allows the estimation of glucose transport and its phosphorylation. A number of kinetic modeling approaches have been used for the quantitation of glucose utilization rates using FDG. FDG is transported and phosphorylated as native glucose, but calculation of glucose uptake and metabolism requires the use of correction factors for each process merged into a lumped constant. The major limitation of these approaches is that quantification of glucose metabolism requires the knowledge of the lumped constant, a factor, which relates the kinetic behavior of FDG to naturally occurring glucose in terms of the relative affinity of each molecule for the trans-sarcolemmal transporter and for hexokinase. Unfortunately, the value of the lumped constant in humans under different physiological and pathophysiological conditions varies, and metabolic imaging with PET need standardization of metabolic conditions by hyperinsulinaemic euglycaemic clamp. 3-OMG appears as an ideal glucose analog to probe transmembrane transport. However, due to the short half-life of the 11C (t1/2 = 20 min), this analog can be used only in clinical institutions in close proximity of a cyclotron and which have access to PET devices.

According to these knowledge, the investigators have developed an original compound, [123I] 6-deoxy-6-iodo-D-glucose (6DIG), as a tracer of glucose transport equivalent to 3-OMG, the reference tracer. 6-DIG has previously been exploited to measure IR in vivo and the investigators transfer to human this measurement technique, perfectly validated in animal. Previous, they have reported the first use a potential single-photon emission computed tomography (SPECT) tracer to study basal and insulin-stimulated glucose transport non-invasively. In a phase I of development, they use a new nuclear probe using an iodinated tracer of glucose transport for clinical application and specific imaging processing to assess cardiac insulinoresistance in healthy or diabetic subjects. The results in human subjects show that this technique rapidly provides insulinoresistance index (ratio scintigraphy measurement of glucose transport in heart before and after infusion of insulin) in a simple procedure, opening up new opportunities for screening for pre-diabetic patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Hôpital Michallon . CHU Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Insulin sensible patients

    • Body mass index < 25 HOMA <= 2.5
    • Waist measurement < 94 cm for men and < 80 cm for women
    • HDL cholesterol 1,03 mmol/L for men and > 1,29 mmol/L for women
    • Triglyceride level ≤ 1,69 mmol/ L
    • For women not menopausal since at last one year or not surgically sterilised:

On-going contraception, physical or hormonal, excepted local methods (spermicidal, diaphragm, condom, cape)

- Insulin resistant patients

  • For women not menopausal since at last one year or not surgically sterilised:
  • On-going contraception, physical or hormonal, excepted local methods (spermicidal, diaphragm, condom, cape)
  • HOMA > 2.5
  • Body mass index > 25
  • Waist measurement > 94 cm for men and > 80 cm for women
  • HDL cholesterol < 1,03 mmol/L et for men and ≤ 1,29 mmol/L for women
  • Triglyceride level > 1,69 mmol/ L

Exclusion Criteria:

  • • Instable cardiomyopathy

    • Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg
    • Psychiatric illness, needing a chronic treatment
    • Previous history of stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer.
    • Allergy to one of the components of the products used during the study
    • Treatment likely to interfere with glucose metabolism
    • Alcohol or drug intoxication
    • Vegetarian or restrictive low-calory diet,
    • Participation in other biomedical research at the same time or exclusion period under another biomedical research
    • Pregnant, parturient or breast-feeding women,
    • Inappropriate way of life

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 6-DIG and clamp
injection of 6-DIG and hyperinsulinemic euglycemic clamp
Drug: 6-DIG
injection of 6-DIG
Procedure: clamp
hyperinsulinemic euglycemic clamp

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation between measure of insulin resistance measurement by scintigraphy and hyperinsulinemic euglycemic clamp
Time Frame: DAY 1 AND DAY 2
Correlation between measure of insulin resistance measurement by scintigraphy (insulin resistance index: ratio scintigraphy measurement of glucose transport in heart before and after infusion of insulin) and hyperinsulinemic euglycemic clamp (Glucose Infusion Rate and sensibility index Clamp)
DAY 1 AND DAY 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SAFETY
Time Frame: visit 2, visit 3 and visit 4
A systematic collection of adverse events
visit 2, visit 3 and visit 4
Reproducibility
Time Frame: day 2 and day 3
Reproducibility inter and intra operator of Insulin resistance index
day 2 and day 3
Left ventricule ejection fraction
Time Frame: day 2
day 2
left ventricle volume
Time Frame: day 2
day 2
cardiac mass
Time Frame: day 2
day 2
diastolic function
Time Frame: day 2
day 2
cardiac output
Time Frame: day 2
day 2
pulmonary pressure and right ventricular function
Time Frame: day 2
day 2
strain by speckle tracking echocardiography
Time Frame: day 2
day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gilles Barone-Rochette, PHU, Hopital Michalon , CHU de Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C13-14
  • 2013-003526-92 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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