LipodystrophyIRAP-DUN 2NCT05424913
Exploratory Study of the Relationships Between the Biomarkers of Inflammation, Lipidome and Insulin Resistance and Disorders of Glycemic Regulation in a Cohort of Insulin-resistant Subjects Due to Excess Weight or Dunnigan's Lipodystrophy
A study testing research-specific blood sample in people with Lipodystrophy and Dunnigan Syndrome, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The objective of this work is to identify biomarkers of interest in patients with insulin resistance leading to early disorders of glycemic regulation. For this the investigators want to assay the insulin resistance marker Insulin Regulated Amino Peptidase serique (IRAPs), the plasma lipidome and inflammation markers… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipodystrophy, Dunnigan Syndrome
- What is being tested?
- research-specific blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteReunion
- Study dates
- 17 Aug 2021to 16 Aug 2023
- 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
- Subjects with Dunnigan's Lipodystrophy OR Non-lipodystrophic insulin-resistant subjects OR Insulin-sensitive non-lipodystrophic subjects
- major
- Subjects benefiting from metabolic exploration in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
- Subject benefiting from an oral glucose tolerance test (OGTT) during his follow-up in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
- Person affiliated or beneficiary of a social security scheme.
- Subject having been informed of the study in progress and having given their written consent.
Who cannot join
- Pregnant woman
- Person under guardianship or curators or deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this work is to identify biomarkers of interest in patients with insulin resistance leading to early disorders of glycemic regulation. For this the investigators want to assay the insulin resistance marker Insulin Regulated Amino Peptidase serique (IRAPs), the plasma lipidome and inflammation markers in 2 populations of insulin-resistant subjects due to Dunnigan's inherited lipodystrophy or overweight/obesity and insulin-sensitive subjects with or without a glycemic regulation disorder objectified during an Oral induced hyperglycemia. The results of the IRAPs, lipidome and inflammation assays will be compared in insulin-resistant subjects, between normoglycemic, prediabetic and diabetic subjects. Correlations will be made between these markers and the deterioration of glycemic regulation as well as with known insulin resistance parameters (HOmeostasis Assessment Model (HOMA), Quantitative Insulin-sensitivity Check Index (QUICKI),Insulin Sensitivity Index (Isi) MATSUDA).
- Conditions
- Lipodystrophy, Dunnigan Syndrome
- Being tested
- research-specific blood sample
- Medical subject headings
- Lipodystrophy, Lipodystrophy, Familial Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
research-specific blood sampleOther
blood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Dunnigan's Lipodystrophy | Other | Not described Receives: Other: research-specific blood sample |
| Non-lipodystrophic insulin-resistant subjects | Other | Not described Receives: Other: research-specific blood sample |
| Insulin-sensitive non-lipodystrophic subjects | Other | Not described Receives: Other: research-specific blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Regulated Amino Peptidase sérique (IRAPs) levels
Insulin Regulated Amino Peptidase sérique (IRAPs)
Measured: at inclusion
inflammation markers levels
TNF-α (tumor necrosis factors-α), IL-1β (interleukin-1β), IL-2, IL-6, IL-18, IFN-γ (interferon-γ) et MCP-1 (monocyte chemoattractant protein-1), IL-10, IL-4, IL-5
Measured: at inclusion
lipidome markers levels
662 plasma lipid species
Measured: at inclusion
Secondary outcomes (3)
Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants
Insulin Regulated Amino Peptidase sérique (IRAPs)
Measured: at inclusion
Compare levels of inflammation markers between the 3 categories of participants
TNF-α (tumor necrosis factors-α), IL-1β (interleukin-1β), IL-2, IL-6, IL-18, IFN-γ (interferon-γ) et MCP-1 (monocyte chemoattractant protein-1), IL-10, IL-4, IL-5
Measured: at inclusion
Compare levels of lipidome markers between the 3 categories of participants
662 plasma lipid species
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 posted21 Jun 2022
- Study start17 Aug 2021
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424913
- Sponsor's protocol ID
- 2017/CHU/07-2021-A00105-36
- Acronym
- IRAP-DUN 2
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Relationships Between the Biomarkers of Inflammation, Lipidome and Insulin Resistance and Disorders of Glycemic Regulation in a Cohort of Insulin-resistant Subjects Due to Excess Weight or Dunnigan's Lipodystrophy
- ClinicalTrials.gov ID
- NCT05424913
- Acronym / sponsor ID
- IRAP-DUN 2 / 2017/CHU/07-2021-A00105-36
- Conditions
- Lipodystrophy, Dunnigan Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- 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 objective of this work is to identify biomarkers of interest in patients with insulin resistance leading to early disorders of glycemic regulation. For this the investigators want to assay the insulin resistance marker Insulin Regulated Amino Peptidase serique (IRAPs), the plasma lipidome and inflammation markers in 2 populations of insulin-resistant subjects due to Dunnigan's inherited lipodystrophy or overweight/obesity and insulin-sensitive subjects with or without a glycemic regulation disorder objectified during an Oral induced hyperglycemia. The results of the IRAPs, lipidome and inflammation assays will be compared in insulin-resistant subjects, between normoglycemic, prediabetic and diabetic subjects. Correlations will be made between these markers and the deterioration of glycemic regulation as well as with known insulin resistance parameters (HOmeostasis Assessment Model (HOMA), Quantitative Insulin-sensitivity Check Index (QUICKI),Insulin Sensitivity Index (Isi) MATSUDA).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with Dunnigan's Lipodystrophy | Other | Other: research-specific blood sample |
| Non-lipodystrophic insulin-resistant subjects | Other | Other: research-specific blood sample |
| Insulin-sensitive non-lipodystrophic subjects | Other | Other: research-specific blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with Dunnigan's Lipodystrophy OR Non-lipodystrophic insulin-resistant subjects OR Insulin-sensitive non-lipodystrophic subjects
- major
- Subjects benefiting from metabolic exploration in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
- Subject benefiting from an oral glucose tolerance test (OGTT) during his follow-up in the Endocrinology, Diabetology and Nutrition department of the Reunion University Hospital.
- Person affiliated or beneficiary of a social security scheme.
Key exclusion criteria (2 listed)
- Pregnant woman
- Person under guardianship or curators or deprived of liberty
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 |
|---|---|---|
| research-specific blood sampleblood sample of 50 ml maximum levels of serum Insulin Regulated Amino Peptidase, lipidome markers and inflammation markers | Other | Insulin-sensitive non-lipodystrophic subjects, Non-lipodystrophic insulin-resistant subjects, Subjects with Dunnigan's Lipodystrophy |
Primary outcome
Insulin Regulated Amino Peptidase sérique (IRAPs) levels
Time frame: at inclusion
Insulin Regulated Amino Peptidase sérique (IRAPs)
inflammation markers levels
Time frame: at inclusion
TNF-α (tumor necrosis factors-α), IL-1β (interleukin-1β), IL-2, IL-6, IL-18, IFN-γ (interferon-γ) et MCP-1 (monocyte chemoattractant protein-1), IL-10, IL-4, IL-5
lipidome markers levels
Time frame: at inclusion
662 plasma lipid species
3 secondary outcomes
Compare levels of Insulin Regulated Amino Peptidase sérique (IRAPs) between the 3 categories of participants
Time frame: at inclusion
Compare levels of inflammation markers between the 3 categories of participants
Time frame: at inclusion
Compare levels of lipidome markers between the 3 categories of participants
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 25 Oct 2023.
- Individual participant dataSharing planned: No
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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?
A study testing research-specific blood sample in people with Lipodystrophy and Dunnigan Syndrome, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 6 inclusion and 2 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 25 Oct 2023. 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 Reunion. 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?
Insulin Regulated Amino Peptidase sérique (IRAPs) levels (time frame: at inclusion). The study lists 3 primary outcomes in all. 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 25 Oct 2023.