Pre-diabetesDECODIABNCT01739868
Screening and Understanding of the Pre-diabetes: DECODIAB
A study testing Biopsies of muscular and fat tissue in people with Pre-diabetes, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Biopsies of muscular and fat tissue
- Type of treatment
- Pill or oral medicine
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Apr 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years)
- Subjects with diabetes risk score ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and < 1 .26 g/L
- And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and < 1 .26 g/L ; or blood glucose ≥ 1g/l and < 1,1 g/L WITH HbA1C ≥ 6,5%
- Signed informed consent
- Subjects affiliated with an appropriate social security system
Who cannot join
- Fasting glycemia ≥ 1.26 g/l
- Fasting glycemia ≤ 1.10 g/l AND HbA1C < 6,5%
- Fasting glycemia < 1 g/l
- Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.
- Subjects previously treated with insulin, except gestational diabetes
- Severe coagulation disorders
Show all 14Show fewer
- Thrombocytopenia < 100 000/mm 3
- Severe psychiatric disorders
- Severe renal insufficiency (creatinine clearance < 30 ml/min)
- Severe hepatic insufficiency
- Alcohol abuse (> 30g/j)
- Contra-indication in the realization of the local anesthetic
- Subject unable to follow the study during the 5 years of follow-up
- Subject exclusion period in a previous study
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes.
- Conditions
- Pre-diabetes
- Being tested
- Biopsies of muscular and fat tissue
- Keywords
- Pre-diabetes, Type 2 diabetes, Biomarkers, Diabetes risk score
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsies of muscular and fat tissueOther
3 half days of metabolic exploration including blood sample, urinary taking, OGTT (oral glucose tolerance test), biopsies of muscular and fat tissue:
- 1 visit the first year (inclusion visit)
- 1 visit at the end of 5 years of follow-up or in the appearance of type 2 diabetes
- 1 intermediary visit (in 3 years) or activated by the following conditions:
- Escalation of the glycemia (increase of 0.1g / l of the glycemia and/or 0.3 % of the HbA1c)
- Normalization of the glycemia (fasting blood glucose < 1 g/l)
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify new biomarkers
The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes
Measured: 5 years
Secondary outcomes (4)
To identify new therapeutic targets
To identify new therapeutic targets for the prevention of the appearance of the diabetes in the population of patients with pre-diabetes
Measured: 5 years
To connect identified biomarkers with the degree of insulinoresistance
To connect identified biomarkers with the degree of insulinoresistance (HOMA-R) and with β pancreatic function (IOG) in the population of patients with pre-diabetes.
Measured: 5 years
Number of patients with high Diabetes Risk Score and pre-diabetes
To evaluate the interest of the Diabetes Risk Score in identifying subjects with pre-diabetes in the French population
Measured: 5 years
Number of patients with others cardiovascular risk factors
To evaluate the prevalence of others cardiovascular risk factors associated with pre-diabetes: dyslipidemia, hypertension, metabolic liver disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand CARIOU, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739868
- Sponsor's protocol ID
- 09/9-A
- Acronym
- DECODIAB
- Status last verified
- Apr 2015
- First submitted
- 23 Nov 2012
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Understanding of the Pre-diabetes: DECODIAB
- ClinicalTrials.gov ID
- NCT01739868
- Acronym / sponsor ID
- DECODIAB / 09/9-A
- Conditions
- Pre-diabetes
- Keywords
- Pre-diabetes, Type 2 diabetes, Biomarkers, Diabetes risk score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 4 Dec 2012 (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 main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years)
- Subjects with diabetes risk score ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and < 1 .26 g/L
- And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and < 1 .26 g/L ; or blood glucose ≥ 1g/l and < 1,1 g/L WITH HbA1C ≥ 6,5%
- Signed informed consent
- Subjects affiliated with an appropriate social security system
Key exclusion criteria (14 listed)
- Fasting glycemia ≥ 1.26 g/l
- Fasting glycemia ≤ 1.10 g/l AND HbA1C < 6,5%
- Fasting glycemia < 1 g/l
- Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.
- Subjects previously treated with insulin, except gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsies of muscular and fat tissue3 half days of metabolic exploration including blood sample, urinary taking, OGTT (oral glucose tolerance test), biopsies of muscular and fat tissue: * 1 visit the first year (inclusion visit) * 1 visit at the end of 5 years of follow-up or in the appearance of type 2 diabetes * 1 intermediary visit (in 3 years) or activated by the following conditions: * Escalation of the glycemia (increase of 0.1g / l of the glycemia and/or 0.3 % of the HbA1c) * Normalization of the glycemia (fasting blood glucose < 1 g/l) | Other | – |
Primary outcome
To identify new biomarkers
Time frame: 5 years
The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes
4 secondary outcomes
To identify new therapeutic targets
Time frame: 5 years
To connect identified biomarkers with the degree of insulinoresistance
Time frame: 5 years
Number of patients with high Diabetes Risk Score and pre-diabetes
Time frame: 5 years
Number of patients with others cardiovascular risk factors
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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.
Bertrand CARIOU, Pr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsies of muscular and fat tissue in people with Pre-diabetes, run by Nantes University Hospital at 1 site in France.
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 14 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 16 Apr 2015. 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 France. 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?
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.
What does the primary outcome measure?
To identify new biomarkers (time frame: 5 years). It is what the study was designed to measure, not a finding.
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 16 Apr 2015.