Development of a Fast Measurement Technique of Insulin Resistance in Human
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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.