Development of a Fast Measurement Technique of Insulin Resistance in Human
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): injection of 6-DIG
Intervention type(s): Drug
Intervention description(s): Unique injection dose of 92.5 MBq
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: metabolic syndrome; type 2 diabetes mellitus; insulin resistance; Scintigraphy