Type 1 and 2 DiabetesNCT02045563
Genetic Polymorphisms, Steatosis and Diabetes
An observational study of Type 1 and 2 Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Our research hypothesis is to show that a certain number of genetic polymorphisms of the proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the development of steatosis in patients with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 and 2 Diabetes
- What is being tested?
- prise de sang and magnetic resonance imaging and magnetic resonance spectroscopy
- How many people
- 507 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2007to 25 Mar 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of type 2 diabetes over 18 subjects treated with diet alone or with oral antidiabetic glitazones outside of patients with type 1 and of age-matched healthy volunteers and sex.
Who may be able to join
- Type 2 diabetes
- HbA1C>6.5%
- 27<BMI<55
- Type 1 diabetes
- BMI<55 Diagnosis of type-1 diabetes based on the clinical history of the patient and/or the presence of anti-glutamate decarboxylase auto antibodies and/or a plasma level of C peptide below 0,5 ng/l.
- Non diabetic
Show all 9Show fewer
- Alcohol consumption < 2 glasses per day
- Without hyperglycemic treatment (corticoids, ...)
- Without liver disease (cirrhosis, hepatitis, ...)
Who cannot join
- Pacemaker
- Daily alcohol consumption above 4 glasses per day
- Patients treated with Glitazones during the 3 months preceding inclusion
- Presence of implants
- Claustrophobia
- Patient < 18 years
- Patient under guardianship or not intellectually independent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Polymorphisms, Hepatic Steatosis and Lipid Anomalies in Diabetic Patients
- Our research hypothesis is to show that a certain number of genetic polymorphisms of the proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the development of steatosis in patients with Type 2 diabetes.
- We also wish to evaluate more thoroughly lipid anomalies associated with the presence of steatosis, notably with regard to monocyte expression of LDL receptors. We hypothesize that hepatic steatosis is accompanied by activation of transcription factors involved in lipogenesis, notably SREBP factors. The activation of these factors could cause an increase in the expression of LDL receptors, leading to increased LDL catabolism.
- Chronological description of the study During an outpatient consultation at the endocrinology department, diabetic patients, programmed to undergo an examination to assess their diabetes will be invited to participate in the study. Once written informed consent has been provided and clinical data has been recorded, patients with type 1 or type 2 diabetes will have standard biological examination, which is systematically done in such patients (Fasting glycemia, HBA1c, aspartate aminotransferase, alanine amino transferase, Gammaglutamyl-transferases, PAL, bilirubin, blood proteins, albuminemia, Total Cholesterol total, HDL cholesterol, triglycerides, Sedimentation Rate, C-reactive protein, fibrinogen).
As well as the systematic biological tests, 3 additional tubes will be taken to screen for genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1, Apolipoprotein A - II).
IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to look for the presence of liver steatosis and to measure carotid intima-media thickness.
- Conditions
- Type 1 and 2 Diabetes
- Being tested
- prise de sang, magnetic resonance imaging and magnetic resonance spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prise de sangOther
magnetic resonance imaging and magnetic resonance spectroscopyOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with type-1 diabetes | Not described Receives: Other: prise de sang; Other: magnetic resonance imaging and magnetic resonance spectroscopy | |
| Patients with type-2 diabetes | Not described Receives: Other: prise de sang; Other: magnetic resonance imaging and magnetic resonance spectroscopy | |
| Volontaires sains | Not described Receives: Other: prise de sang; Other: magnetic resonance imaging and magnetic resonance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the existence of liver steatosis measured by magnetic resonance spectroscopy spectrometry
Measured: At inclusion
Secondary outcomes (1)
Measurement of monocyte expression of LDL receptors
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study start15 Oct 2007
- Primary completion25 Mar 2015
- Study completion25 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 and 2 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
- Other
- Time perspective
- Prospective
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045563
- Sponsor's protocol ID
- PETIT PARI 2011
- Status last verified
- Feb 2024
- First submitted
- 21 Jan 2014
- Last updated
- 21 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms, Hepatic Steatosis and Lipid Anomalies in Diabetic Patients
- ClinicalTrials.gov ID
- NCT02045563
- Acronym / sponsor ID
- PETIT PARI 2011
- Conditions
- Type 1 and 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 15 Oct 2007 (actual)
- Primary completion
- 25 Mar 2015 (actual)
- Study completion
- 25 Mar 2015 (actual)
- First posted
- 27 Jan 2014 (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.
- Our research hypothesis is to show that a certain number of genetic polymorphisms of the proteins involved in glucose, lipid and adipocyte metabolism are factors that favour the development of steatosis in patients with Type 2 diabetes.
- We also wish to evaluate more thoroughly lipid anomalies associated with the presence of steatosis, notably with regard to monocyte expression of LDL receptors. We hypothesize that hepatic steatosis is accompanied by activation of transcription factors involved in lipogenesis, notably SREBP factors. The activation of these factors could cause an increase in the expression of LDL receptors, leading to increased LDL catabolism.
- Chronological description of the study During an outpatient consultation at the endocrinology department, diabetic patients, programmed to undergo an examination to assess their diabetes will be invited to participate in the study. Once written informed consent has been provided and clinical data has been recorded, patients with type 1 or type 2 diabetes will have standard biological examination, which is systematically done in such patients (Fasting glycemia, HBA1c, aspartate aminotransferase, alanine amino transferase, Gammaglutamyl-transferases, PAL, bilirubin, blood proteins, albuminemia, Total Cholesterol total, HDL cholesterol, triglycerides, Sedimentation Rate, C-reactive protein, fibrinogen).
As well as the systematic biological tests, 3 additional tubes will be taken to screen for genetic polymorphism in 3 proteins (Microsomal Transfer Protein, Adiponectin receptor - 1, Apolipoprotein A - II).
IN addition, magnetic resonance imaging and magnetic resonance spectroscopy will be done to look for the presence of liver steatosis and to measure carotid intima-media thickness.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with type-1 diabetes | – | Other: prise de sang, Other: magnetic resonance imaging and magnetic resonance spectroscopy |
| Patients with type-2 diabetes | – | Other: prise de sang, Other: magnetic resonance imaging and magnetic resonance spectroscopy |
| Volontaires sains | – | Other: prise de sang, Other: magnetic resonance imaging and magnetic resonance spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of type 2 diabetes over 18 subjects treated with diet alone or with oral antidiabetic glitazones outside of patients with type 1 and of age-matched healthy volunteers and sex.
Key inclusion criteria (9 listed)
- Type 2 diabetes
- HbA1C>6.5%
- 27<BMI<55
- Type 1 diabetes
- BMI<55 Diagnosis of type-1 diabetes based on the clinical history of the patient and/or the presence of anti-glutamate decarboxylase auto antibodies and/or a plasma level of C peptide below 0,5 ng/l.
Key exclusion criteria (8 listed)
- Pacemaker
- Daily alcohol consumption above 4 glasses per day
- Patients treated with Glitazones during the 3 months preceding inclusion
- Presence of implants
- Claustrophobia
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 |
|---|---|---|
| prise de sang | Other | Patients with type-1 diabetes, Patients with type-2 diabetes, Volontaires sains |
| magnetic resonance imaging and magnetic resonance spectroscopy | Other | Patients with type-1 diabetes, Patients with type-2 diabetes, Volontaires sains |
Primary outcome
Determination of the existence of liver steatosis measured by magnetic resonance spectroscopy spectrometry
Time frame: At inclusion
1 secondary outcome
Measurement of monocyte expression of LDL receptors
Time frame: At inclusion
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 21 Feb 2024.
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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 Type 1 and 2 Diabetes, run by Centre Hospitalier Universitaire Dijon 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 9 inclusion and 8 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 21 Feb 2024. 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?
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?
Determination of the existence of liver steatosis measured by magnetic resonance spectroscopy spectrometry (time frame: At inclusion). 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 21 Feb 2024.