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Development of a Fast Measurement Technique of Insulin Resistance in Human (GLUCIMAG)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
injection of 6-DIG
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes Mellitus focused on measuring metabolic syndrome, type 2 diabetes mellitus, insulin resistance, Scintigraphy

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • Aged between 35 et 60 years old
  • Body mass index between 20 and 25
  • Waist measurement < 94 cm for men and < 80 cm for women
  • Normal basal glycemia, between 3,8 and 5,8 mmol/l
  • Normal basal insulinemia, between 3 and 13 μUI/ml
  • HbA1c < 6%
  • Total cholesterol < 2 g/l
  • LDL cholesterol < 1,6 g/l
  • HDL cholesterol 0,4 g/l for men and 0,5 g/l for women
  • Triglyceride level < 1,5 g/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)

  • Type 2 diabetic patients
  • Aged between 35 et 60 years old
  • Stable type 2 diabetes mellitus: no ketoacidosis sign during last month
  • HbA1c between 6 and 8% during the 3 months before study inclusion
  • Monotherapy by metformin or diet only
  • 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)

Exclusion Criteria:

  • Diabetes mellitus previously known
  • Other on-going progressive illness
  • Psychiatric illness, needing a chronic treatment
  • Previous history of myocardial infarction, coronary artery disease, cardiac rhythm troubles, stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer.
  • Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg
  • Allergy to one of the components of the products used during the study
  • Nuclear medicine examination during the 30 days prior to study inclusion
  • Treatment likely to interfere with glucose metabolism
  • Alcohol or drug intoxication
  • Vegetarian or restrictive low-calory diet,
  • Pregnant, parturient or breast-feeding women,
  • Inappropriate way of life
  • Type 2 diabetic patients.
  • Previous history of myocardial infarction
  • Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg
  • Previous history of coronary artery disease, cardiac rhythm troubles, stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer.
  • Psychiatric illness, needing a chronic treatment
  • On-going insulin treatment
  • On-going treatment other than metformin, likely to interfere with glucose metabolism
  • Previous history of 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
  • Nuclear medicine examination during the 30 days prior to study inclusion
  • Alcohol or drug intoxication
  • Vegetarian or restrictive low-calory diet,
  • Pregnant, parturient or breast-feeding women,
  • Inappropriate way of life

Sites / Locations

  • Service de Biophysique et Médecine Nucléaire, CHU de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy volunteers

type 2 diabetic patients

Arm Description

First injection in human, on 6 healthy volunteers, sequentially : volunteer number1, then volunteers n°2 to n° 6, before infusion in type 2 diabetic patients.

After completion of the study for the 6 healthy volunteers, infusion in 6 type 2 diabetic patients.

Outcomes

Primary Outcome Measures

Change of glycemia
Assessment of tolerance to insulin resistance measurement technique with 6-DIG scintigraphy, in healthy volunteers clinical tolerance to 6-DIG infusion clinical and biological tolerance to insulin infusion evaluation of dosimetry

Secondary Outcome Measures

insulinemia
clinical side effects
hypoglycemia symptoms
dosimetry
organs biodistribution of radioactivity
insulin resistance
scintigraphic measurement of glucose transport in heart before and after infusion of insulin

Full Information

First Posted
April 28, 2010
Last Updated
February 23, 2016
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01493934
Brief Title
Development of a Fast Measurement Technique of Insulin Resistance in Human
Acronym
GLUCIMAG
Official Title
Development of a Fast Measurement Technique of Insulin Resistance in Human, With 123-6-deoxy-6 Iodo-D-glucose, a New Tracer of Glucose Transport
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Insulin resistance, characterised by a depressed cellular sensitivity to insulin in insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality, whatever the cause, but, as a majority, cardiovascular diseases. In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led to grow in a near future, because of the increase of diabetes mellitus and obesity prevalence. Actually, 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. Within the investigators U877 INSERM team, the investigators previously performed in vivo biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose transport, radiolabelled with123 iodine, with and without insulin, on the one hand in genetically diabetic mice (db/db), consequently having a severe insulin resistance and in the other hand in rats with acquired insulin resistance after a "fructose diet". The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose transport variations in insulin sensible organs. Then, the investigators developed a fast and simple imaging protocol with a small animal gamma camera, which allows the obtaining of an insulin resistance index for each organ, directly transferable to human. The investigators project is to transfer to human this measurement technique, perfectly validated in animal. The main goal of this monocentric phase I-II study is to evaluate the tolerance to the insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and in diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2 diabetic patients. The investigators secondary goals will be to evaluate feasibility and reproducibility of the measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure insulin resistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
metabolic syndrome, type 2 diabetes mellitus, insulin resistance, Scintigraphy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
First injection in human, on 6 healthy volunteers, sequentially : volunteer number1, then volunteers n°2 to n° 6, before infusion in type 2 diabetic patients.
Arm Title
type 2 diabetic patients
Arm Type
Experimental
Arm Description
After completion of the study for the 6 healthy volunteers, infusion in 6 type 2 diabetic patients.
Intervention Type
Drug
Intervention Name(s)
injection of 6-DIG
Intervention Description
Unique injection dose of 92.5 MBq
Primary Outcome Measure Information:
Title
Change of glycemia
Description
Assessment of tolerance to insulin resistance measurement technique with 6-DIG scintigraphy, in healthy volunteers clinical tolerance to 6-DIG infusion clinical and biological tolerance to insulin infusion evaluation of dosimetry
Time Frame
Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)
Secondary Outcome Measure Information:
Title
insulinemia
Time Frame
Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)
Title
clinical side effects
Description
hypoglycemia symptoms
Time Frame
Before inclusion in clinical trial, Before radiotracer injection, After radiotracer injection (time: 30s, 1', 2',5',10',15',25', 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)
Title
dosimetry
Description
organs biodistribution of radioactivity
Time Frame
during the 24 hours following injection of 6-DIG
Title
insulin resistance
Description
scintigraphic measurement of glucose transport in heart before and after infusion of insulin
Time Frame
0-15 minutes following 6-DIG infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Aged between 35 et 60 years old Body mass index between 20 and 25 Waist measurement < 94 cm for men and < 80 cm for women Normal basal glycemia, between 3,8 and 5,8 mmol/l Normal basal insulinemia, between 3 and 13 μUI/ml HbA1c < 6% Total cholesterol < 2 g/l LDL cholesterol < 1,6 g/l HDL cholesterol 0,4 g/l for men and 0,5 g/l for women Triglyceride level < 1,5 g/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) Type 2 diabetic patients Aged between 35 et 60 years old Stable type 2 diabetes mellitus: no ketoacidosis sign during last month HbA1c between 6 and 8% during the 3 months before study inclusion Monotherapy by metformin or diet only 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) Exclusion Criteria: Diabetes mellitus previously known Other on-going progressive illness Psychiatric illness, needing a chronic treatment Previous history of myocardial infarction, coronary artery disease, cardiac rhythm troubles, stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer. Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg Allergy to one of the components of the products used during the study Nuclear medicine examination during the 30 days prior to study inclusion Treatment likely to interfere with glucose metabolism Alcohol or drug intoxication Vegetarian or restrictive low-calory diet, Pregnant, parturient or breast-feeding women, Inappropriate way of life Type 2 diabetic patients. Previous history of myocardial infarction Severe hypertension defined by par SAP > 180 mmHg and/or DAP > 110 mmHg Previous history of coronary artery disease, cardiac rhythm troubles, stroke, epilepsy, cranial trauma, pituitary surgery, disease likely to reduce the ability of absorption, diffusion or excretion of the radiotracer. Psychiatric illness, needing a chronic treatment On-going insulin treatment On-going treatment other than metformin, likely to interfere with glucose metabolism Previous history of 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 Nuclear medicine examination during the 30 days prior to study inclusion Alcohol or drug intoxication Vegetarian or restrictive low-calory diet, Pregnant, parturient or breast-feeding women, Inappropriate way of life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Calizzano, MD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alex Calizzano, MD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Study Chair
Facility Information:
Facility Name
Service de Biophysique et Médecine Nucléaire, CHU de Grenoble
City
Grenoble
Country
France

12. IPD Sharing Statement

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Development of a Fast Measurement Technique of Insulin Resistance in Human

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