A Phase 1/2 interventional study of injection of 6-DIG in Type 2 Diabetes Mellitus, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 1 site in France. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Phase 1/2, Interventional, and Diagnostic
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 375 studies on the registry; 82 are open to participants now.
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On-going contraception, physical or hormonal, excepted local methods (spermicidal, diaphragm, condom, cape)
Exclusion Criteria:
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.
Drug: injection of 6-DIG
After completion of the study for the 6 healthy volunteers, infusion in 6 type 2 diabetic patients.
Drug: injection of 6-DIG
Unique injection dose of 92.5 MBq
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
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)
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)
clinical side effects
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)
dosimetry
organs biodistribution of radioactivity
Time frame: during the 24 hours following injection of 6-DIG
insulin resistance
scintigraphic measurement of glucose transport in heart before and after infusion of insulin
Time frame: 0-15 minutes following 6-DIG infusion
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Institut National de la Santé Et de la Recherche Médicale, France