Glucose IntoleranceNCT00264940
Diagnosis of Insulin Resistance: 13C-Glucose Breath Test Vs HOMA Index.
An observational study of Glucose Intolerance and Insulin Resistance, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glucose Intolerance, Insulin Resistance, Diabetes Mellitus, Type 2
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Must be able to fast over night
- A blood sample should be drawn
Who cannot join
- Insulin dependent diabetes
- Pulmunary disorder
- Gastrointestinal disorder
- Endocrine disorder
About this study
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.
- Medical subject headings
- Glucose Intolerance, Insulin Resistance, Diabetes Mellitus, Type 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Zamir Halprn, MD, Study chairIlana Goldiner, PhD, Principal investigatorYochanan Peled, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264940
- Sponsor's protocol ID
- TASMC-05-ZH-315-CTIL
- Status last verified
- Dec 2005
- First submitted
- 12 Dec 2005
- Last updated
- 13 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Insulin Resistance: 13C-Glucose Breath Test Vs HOMA Index.
- ClinicalTrials.gov ID
- NCT00264940
- Acronym / sponsor ID
- TASMC-05-ZH-315-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- First posted
- 13 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be able to fast over night
- A blood sample should be drawn
Key exclusion criteria (4 listed)
- Insulin dependent diabetes
- Pulmunary disorder
- Gastrointestinal disorder
- Endocrine disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zamir Halprn, MD study chair
Ilana Goldiner, PhD principal investigator
Yochanan Peled, PhD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Intolerance and Insulin Resistance, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2005.