Diagnosis of Insulin Resistance: 13C-Glucose Breath Test Vs HOMA Index.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00264940
Recruitment Status : Unknown
Verified December 2005 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2005
Last Update Posted : December 13, 2005
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
The prevalence of type 2 diabetes is rising in the population for many years. It is now recognized that a period of glucose intolerance precedes the clinical symptoms appearance. This is due to a combination of b-cell dysfunction and insulin resistance. It is estimated that this pre-clinical phase of type 2diabetes may antedate the onset of overt diabetes by 10-12 years. Furthermore, insulin resistance is considered to be a main component of the metabolic syndrome and associated with significant cardiovascular morbidity and mortality. Recently, there has been an effort to pinpoint the pre-diabetic phase for early therapeutic intervention in the individual. These studies, in patients with impaired glucose intolerance, have shown to be beneficial from both lifestyle change and pharmacological intervention. It is thus hypnotized that intervention in patients with insulin resistance with or without glucose intolerance may prevent the progress of type 2 diabetes and it’s complications. There is difficulty in identifying individuals who are at high risk for type 2 diabetes. The prevention strategy relies on intervention in a pre-diseased state. In the case of type 2 diabetes, the early intervention is useful in the phase where there is insulin resistance, but prior to the appearance of glucose intolerance. The diagnosis of insulin resistance is a challenging one. The gold standard in diagnosing insulin resistance is the hyperinsulinemic-euglycemic clamp, but this method is not suitable for routine clinical use. Thus, less invasive methods for evaluation, like homeostasis model assessment (HOMA) and quantitative insulin sensitivity check index (QUICKI), were developed. There is a correlation between HOMA and QUICKI results and the hyperinsulinemic-euglycemic clamp. Both HOMA and QUICKI allow insulin resistance diagnosis. The results from those tests correlate with hyperinsulinemic-euglycemic clamp and allow diagnosing insulin resistance, however, those indexes require serum glucose, insulin measurements and quite complicated calculations. A new method was suggested, non-invasive, sensitive and simple, for the identification of insulin resistance. In normal individuals, in the presence of insulin, glucose is taken up by a variety of cells, undergoes glycolysis and enters the tricarboxylic acid cycle or fat synthesis. In either case, CO2 in produced as a by-product. This CO2 enters the circulation and is discarded by the lungs. The new method is based on the assumption that 13C-glucose is ingested as described and its by-product 13CO2 can be measured in the expired air. In type 2 diabetes and other states of insulin resistance glucose, uptake is impaired and results in blunted 13CO2 production. This hypothesis was tested by Lewanczuc et al. The writers compared the [13C]-glucose breath test with hyperinsulinemic-euglycemic clamp, HOMA and QUICKI indexes. They tested 26 patients at different stages of insulin sensitivity and reported a good correlation of the glucose breath test and the other indexes. We suggest testing a larger group of patients at high-risk to develop type 2 diabetes and compare the glucose breath test with HOMA index.

Condition or disease
Glucose Intolerance Insulin Resistance Diabetes Mellitus, Type 2

Study Type : Observational

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Must be able to fast over night
  • A blood sample should be drawn

Exclusion Criteria:

  • Insulin dependent diabetes
  • Pulmunary disorder
  • Gastrointestinal disorder
  • Endocrine disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00264940

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Study Chair: Zamir Halprn, MD
Principal Investigator: Ilana Goldiner, PhD
Principal Investigator: Yochanan Peled, PhD Identifier: NCT00264940     History of Changes
Other Study ID Numbers: TASMC-05-ZH-315-CTIL
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: December 13, 2005
Last Verified: December 2005

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases