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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Criteria

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