Pre-DiabetesGENFIEVNCT00879801
Genetic Physiopathology and Evolution of Type 2 Diabetes
An observational study of Pre-Diabetes, run by University of Pisa at 1 site in Italy.
Trial summary
There are few longitudinal studies in the Caucasian population and even less in the Italian population in subjects with impaired glucose regulation to allow: 1. An estimate of the rate of conversion to type 2 diabetes; 2. To identify subjects at risk; and 3. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Pre-Diabetes
- How many people
- 1,017 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2003to Dec 2008
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from outpatients diabetic units located in different areas of Italy.
Who may be able to join
- Each consecutive subject referred to a diabetes clinic for a diagnostic OGTT meeting the above criteria will be assessed as a potential candidate for the study till a total recruitment of 75 individuals will be reached.
- The OGTT will be performed after an overnight fast as described below.
- Individuals with IGT (FPG value of < 7.0 mmol/l, and 2-h PG > 7.8 and < 11.1 mmol/l), IFG (FPG > 6.1 and < 7.0 mmol/l, and 2-h PG value of < 11.1 mmol/l).
- Subjects who had both IFG and IGT will included as well.
- Subjects with normal glucose tolerance (FPG <6.1 and 2-h PG <7.8 mmol/l) will be also recruited as controls
Who cannot join
- Use of drugs known to interfere with glucose metabolism (corticosteroids, beta-blockers, etc)
- Pregnant women, women who are breast feeding
- Active arterial disease (unstable angina, myocardial infarction, cerebrovascular accident, etc) within 3 months of trial entry
- History of malignancy
- Uncontrolled hypertension or hypothyroidism; history of alcohol, or drug abuse, or both
- Active liver disease
- Subjects tacking cyclic hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Genetic, Biochemical and Clinical Determinants of Type 2 Diabetes Progression in Subjects at High Risk
There are few longitudinal studies in the Caucasian population and even less in the Italian population in subjects with impaired glucose regulation to allow:
- An estimate of the rate of conversion to type 2 diabetes;
- To identify subjects at risk; and
- To assess the physiopathologic mechanisms responsible for the conversion.
Read more
In order to set up a longitudinal study capable of defining the above parameters it is mandatory that the physiological, biochemical, and, genetic markers specific for IGR are identified. The goals of the present research proposal are:
- To clarify the physiological mechanisms responsible for IGR;
- To identify the biochemical and beta-cell auto-immune parameters present in IGR;
- Identify genetic markers.
The subjects who will be identified will add up to other 900 individuals who will be recruited as part of a follow-up program sponsored by the Italian Society of Diabetes, specifically designed to assess conversion rate to diabetes.
Read the detailed description
The main goal of the present research program is to recruit about 600 new subjects with IGR to be added to the 900 subjects which are collected as part of the GENFIEV project which has been designed as a 6-yr follow-up study to ascertain the rate of conversion to type 2 diabetes in the Italian population. In particular the goal of the present research program will be to determine in a sample of the Italian population at greater risk for type 2 diabetes than the general population:
- the pathophysiologic mechanisms responsible for the disorders of impaired glucose regulation (IGR). In particular we will evaluate insulin action and insulin secretion as a function of the degree of glucose tolerance by analyzing these parameters in normal subjects as well as in IFG/NGT, NFG/IGT, and IFG/IGT individuals;
- the biochemical markers associated with the disorders of impaired glucose regulation (IGR). In particular we will evaluate several biochemical parameters (lipid profile, coagulative profile, microlbuminuria, free-fatty acids, PAI-1, fibrinogen, creatinine, uric acid, HbA1c);
- the cardiovascular risk profile associated with the disorders of impaired glucose regulation (IGR). In particular, the relevant biochemical parameters will be integrated with measurements of arterial blood pressure as well as ECG recording;
- the genetic markers associated with the disorders of impaired glucose regulation (IGR). In particular subjects will be screened for HHEX, IGF2,BP2 CDKAL1,TCF2L7, CDKN2A/B,WFS1;
- the impact of environmental factors on the disorders of impaired glucose regulation (IGR).
Finally, we will endeavour to assess the cellular pathways that may be affected by metabolic alterations typically occurring in concomitance with the disorders of impaired glucose regulation (IGR).
- Conditions
- Pre-Diabetes
- Keywords
- prevention of diabetes, susceptibility genes, type 2 diabetes, insulin resistance, beta-cell funtion
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with IGR | Subjects at high risk of diabetes, such as those with impaired glucose regulation (IFG and or IGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of conversion to diabetes of IGR subjects carrier of type 2 diabetes susceptibility genes
Measured: December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startJan 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Society of Diabetology, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879801
- Sponsor's protocol ID
- GENFIEV
- Acronym
- GENFIEV
- Status last verified
- Apr 2009
- First submitted
- 9 Apr 2009
- Last updated
- 10 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bianchi C, Miccoli R, Trombetta M, Giorgino F, Frontoni S, Faloia E, Marchesini G, Dolci MA, Cavalot F, Cavallo G, Leonetti F, Bonadonna RC, Del Prato S; GENFIEV Investigators. Elevated 1-hour postload plasma glucose levels identify subjects with normal glucose tolerance but impaired beta-cell function, insulin resistance, and worse cardiovascular risk profile: the GENFIEV study. J Clin Endocrinol Metab. 2013 May;98(5):2100-5. doi: 10.1210/jc.2012-3971. Epub 2013 Mar 28.
PubMed 23539736
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Genetic, Biochemical and Clinical Determinants of Type 2 Diabetes Progression in Subjects at High Risk
- ClinicalTrials.gov ID
- NCT00879801
- Acronym / sponsor ID
- GENFIEV / GENFIEV
- Conditions
- Pre-Diabetes
- Keywords
- prevention of diabetes, susceptibility genes, type 2 diabetes, insulin resistance, beta-cell funtion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,017 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Italian Society of Diabetology, Eli Lilly and Company
- Study start
- Jan 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Apr 2009 (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.
There are few longitudinal studies in the Caucasian population and even less in the Italian population in subjects with impaired glucose regulation to allow:
- An estimate of the rate of conversion to type 2 diabetes;
- To identify subjects at risk; and
- To assess the physiopathologic mechanisms responsible for the conversion.
In order to set up a longitudinal study capable of defining the above parameters it is mandatory that the physiological, biochemical, and, genetic markers specific for IGR are identified. The goals of the present research proposal are:
- To clarify the physiological mechanisms responsible for IGR;
- To identify the biochemical and beta-cell auto-immune parameters present in IGR;
- Identify genetic markers.
The subjects who will be identified will add up to other 900 individuals who will be recruited as part of a follow-up program sponsored by the Italian Society of Diabetes, specifically designed to assess conversion rate to diabetes.
Detailed description
The main goal of the present research program is to recruit about 600 new subjects with IGR to be added to the 900 subjects which are collected as part of the GENFIEV project which has been designed as a 6-yr follow-up study to ascertain the rate of conversion to type 2 diabetes in the Italian population. In particular the goal of the present research program will be to determine in a sample of the Italian population at greater risk for type 2 diabetes than the general population:
- the pathophysiologic mechanisms responsible for the disorders of impaired glucose regulation (IGR). In particular we will evaluate insulin action and insulin secretion as a function of the degree of glucose tolerance by analyzing these parameters in normal subjects as well as in IFG/NGT, NFG/IGT, and IFG/IGT individuals;
- the biochemical markers associated with the disorders of impaired glucose regulation (IGR). In particular we will evaluate several biochemical parameters (lipid profile, coagulative profile, microlbuminuria, free-fatty acids, PAI-1, fibrinogen, creatinine, uric acid, HbA1c);
- the cardiovascular risk profile associated with the disorders of impaired glucose regulation (IGR). In particular, the relevant biochemical parameters will be integrated with measurements of arterial blood pressure as well as ECG recording;
- the genetic markers associated with the disorders of impaired glucose regulation (IGR). In particular subjects will be screened for HHEX, IGF2,BP2 CDKAL1,TCF2L7, CDKN2A/B,WFS1;
- the impact of environmental factors on the disorders of impaired glucose regulation (IGR).
Finally, we will endeavour to assess the cellular pathways that may be affected by metabolic alterations typically occurring in concomitance with the disorders of impaired glucose regulation (IGR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with IGR | – | –Subjects at high risk of diabetes, such as those with impaired glucose regulation (IFG and or IGT) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from outpatients diabetic units located in different areas of Italy.
Key inclusion criteria (5 listed)
- Each consecutive subject referred to a diabetes clinic for a diagnostic OGTT meeting the above criteria will be assessed as a potential candidate for the study till a total recruitment of 75 individuals will be reached.
- Subjects who had both IFG and IGT will included as well.
- Subjects with normal glucose tolerance (FPG <6.1 and 2-h PG <7.8 mmol/l) will be also recruited as controls
Key exclusion criteria (7 listed)
- Use of drugs known to interfere with glucose metabolism (corticosteroids, beta-blockers, etc)
- Pregnant women, women who are breast feeding
- Active arterial disease (unstable angina, myocardial infarction, cerebrovascular accident, etc) within 3 months of trial entry
- History of malignancy
- Uncontrolled hypertension or hypothyroidism; history of alcohol, or drug abuse, or both
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
The rate of conversion to diabetes of IGR subjects carrier of type 2 diabetes susceptibility genes
Time frame: December 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2009.
- Derived from this study: PubMed 23539736Bianchi C, Miccoli R, Trombetta M, Giorgino F, Frontoni S, Faloia E, Marchesini G, Dolci MA, Cavalot F, Cavallo G, Leonetti F, Bonadonna RC, Del Prato S; GENFIEV Investigators. Elevated 1-hour postload plasma glucose levels identify subjects with normal glucose tolerance but impaired beta-cell function, insulin resistance, and worse cardiovascular risk profile: the GENFIEV study. J Clin Endocrinol Metab. 2013 May;98(5):2100-5. doi: 10.1210/jc.2012-3971. Epub 2013 Mar 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Diabetes, run by University of Pisa at 1 site in Italy.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 10 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
The rate of conversion to diabetes of IGR subjects carrier of type 2 diabetes susceptibility genes (time frame: December 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879801, which also lists 1 linked publication.
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 10 Apr 2009.