Diabetes Mellitus, Type 2NCT00520962
Screening for Undiagnosed Type 2 Diabetes in New Classes of Subjects at High Risk
An observational study of Diabetes Mellitus, Type 2, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at high risk to develop alterations of glucose metabolism and definition of new pathogenic mechanisms of insulin resistance and atherosclerosis. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 1,997 participants
- Where
- 1 siteItaly
- Study dates
- Jun 1997to May 2006
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fasting glucose levels <126 mg/dl
- Age >30 years
- Both male and female
Who cannot join
- Type 1 diabetes
- Known type 2 diabetes mellitus
- Pregnancy
- Impaired kidney and liver function
- Previous history of malignancies
Trial locations and contacts
1 site in 1 country.
Italy1 site
Medicine Division, Diabetology, Endocrinology and Metabolic Disease Unit, IRCCS San Raffaele
Milan, 20132
About this study
Official title: New Physiopathogenics Mechanisms Susceptible of Pharmacological Developments (Insulin Resistance and Atherosclerosis)
The study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at high risk to develop alterations of glucose metabolism and definition of new pathogenic mechanisms of insulin resistance and atherosclerosis.
The following classes of subjects at high risk will be considered:First degree relatives of patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke, patients with heart valve disease. age will be > 30 years, both gender.
Read the detailed description
The primary outcome of the study is evaluation of glucose tolerance, insulin sensitivity and insulin secretion before and 2 hours post-glucose load Secondary outcomes are evaluation of endothelial function, of natriuretic peptides and free fatty acids, and inflammation before and 2 hours post-glucose load. New candidate genes will be also evaluated.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- cardiovascular disease, glucose intolerance, type 2 diabetes, endothelial dysfunction, inflammation, Age> 30 years, male and female, Fasting glucose below 126 mg/dl
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Glucose Intolerance, Inflammation
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 |
|---|---|---|
| 1,2,3 | 1. First degree relatives of patients with type 2 diabetes 2. Patients with cardiovascular disease and stroke 3. patients with heart valve disease | |
| 4 | Healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startJun 1997
- Study completionMay 2006
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 1,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- PierMarco Piatti, MD, Principal investigator, IRCSS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520962
- Sponsor's protocol ID
- 199402-1369/516
- Status last verified
- Aug 2007
- First submitted
- 24 Aug 2007
- Last updated
- 27 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Monti LD, Lucotti PC, Setola E, Rossodivita A, Pala MG, Galluccio E, LaCanna G, Castiglioni A, Cannoletta M, Meloni C, Zavaroni I, Bosi E, Alfieri O, Piatti PM. Effects of chronic elevation of atrial natriuretic peptide and free fatty acid levels in the induction of type 2 diabetes mellitus and insulin resistance in patients with mitral valve disease. Nutr Metab Cardiovasc Dis. 2012 Jan;22(1):58-65. doi: 10.1016/j.numecd.2010.04.005. Epub 2010 Aug 14.
PubMed 20709514
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Physiopathogenics Mechanisms Susceptible of Pharmacological Developments (Insulin Resistance and Atherosclerosis)
- ClinicalTrials.gov ID
- NCT00520962
- Acronym / sponsor ID
- 199402-1369/516
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- cardiovascular disease, glucose intolerance, type 2 diabetes, endothelial dysfunction, inflammation, Age> 30 years, male and female, Fasting glucose below 126 mg/dl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,997 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jun 1997
- Study completion
- May 2006 (actual)
- First posted
- 27 Aug 2007 (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 study aims to evaluate IFG, IGT or unknown type 2 diabetes mellitus in new classes at high risk to develop alterations of glucose metabolism and definition of new pathogenic mechanisms of insulin resistance and atherosclerosis.
The following classes of subjects at high risk will be considered:First degree relatives of patients with type 2 diabetes mellitus, patients with cardiovascular disease and stroke, patients with heart valve disease. age will be > 30 years, both gender.
Detailed description
The primary outcome of the study is evaluation of glucose tolerance, insulin sensitivity and insulin secretion before and 2 hours post-glucose load Secondary outcomes are evaluation of endothelial function, of natriuretic peptides and free fatty acids, and inflammation before and 2 hours post-glucose load. New candidate genes will be also evaluated.
Study design
- Observational model
- Defined population
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1,2,3 | – | –1. First degree relatives of patients with type 2 diabetes 2. Patients with cardiovascular disease and stroke 3. patients with heart valve disease |
| 4 | – | –Healthy controls |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fasting glucose levels <126 mg/dl
- Age >30 years
- Both male and female
Key exclusion criteria (5 listed)
- Type 1 diabetes
- Known type 2 diabetes mellitus
- Pregnancy
- Impaired kidney and liver function
- Previous history of malignancies
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
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 27 Aug 2007.
- Derived from this study: PubMed 20709514Monti LD, Lucotti PC, Setola E, Rossodivita A, Pala MG, Galluccio E, LaCanna G, Castiglioni A, Cannoletta M, Meloni C, Zavaroni I, Bosi E, Alfieri O, Piatti PM. Effects of chronic elevation of atrial natriuretic peptide and free fatty acid levels in the induction of type 2 diabetes mellitus and insulin resistance in patients with mitral valve disease. Nutr Metab Cardiovasc Dis. 2012 Jan;22(1):58-65. doi: 10.1016/j.numecd.2010.04.005. Epub 2010 Aug 14.
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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.
PierMarco Piatti, MD principal investigator
IRCSS San Raffaele
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 Diabetes Mellitus, Type 2, run by IRCCS San Raffaele 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 3 inclusion and 5 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 27 Aug 2007. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00520962, 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 27 Aug 2007.