Type2 Diabetes MellitusNCT04107259
IRAPe, Irisin and IL-34 in Patients With Type 2 Diabetes
An observational study of Type2 Diabetes Mellitus, run by Damanhour University at 1 site in Egypt.
Trial summary
Aim: This study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (IRAPe), IL-34, Irisin, and Visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Blood sample
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jan 2019to 20 Jul 2019
- How long will I take part?
- 2 Months
- 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 35 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with type 2 diabetes mellitus were diagnosed according to the criteria of the World Health Organization. All individuals included in this study were adult Middle-Eastern Egyptian citizens and were subjected to full medical history and physical examination by hospital physicians.
Who may be able to join
- newly diagnosed type 2 diabetes and non-diabetic control subjects from 35 to 65 years old were enrolled in this study.
Who cannot join
- individuals with inflammatory diseases, Cushing's syndrome, thyroid disorders, infectious diseases, cancers, hepatic diseases and renal impairment. Subjects on insulin or other medications that could affect glucose metabolism or pro-inflammatory cytokines assessment (Glucocorticoids, beta-Adrenergic agonists, Thiazides, etc.....) were also excluded from study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating IRAPe, Irisin and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes
Aim: This study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (IRAPe), IL-34, Irisin, and Visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus.
Methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio.
Read the detailed description
Aim: This study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (IRAPe), IL-34, Irisin, and Visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus.
Methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio. Anthropometric parameters, blood glucose, fasting plasma insulin, insulin resistance index (HOMA-IR), IL34, Irisin, IRAPe, Visfatin and glycated hemoglobin were assessed.
Conclusion: IL-34 and Visfatin levels were significantly increased, while both Irisin and IRAPe levels were significantly decreased in patients with type 2 diabetes. Theses aforementioned parameters were significantly correlated with insulin resistance. These findings indicate that, IL-34, Irisin and IRAPe may play a vital role in T2DM and in diabetes associated insulin resistance. Additionally, the investigator's findings proposed that, IRAPe may be a useful and direct marker for detection of insulin resistance state.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Blood sample
- Keywords
- Type 2 diabetes mellitus, IL-34, Irisin, IRAPe, Visfatin, Insulin resistance, HOMA-IR
- Medical subject headings
- 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.
Blood sampleDiagnostic test
Ten ml of venous blood was collected from all participants in the early morning after an overnight 12 hour fast by venipuncture of the antecubital vein into sterile tubes. Plasma and sera were separated immediately and were stored at -70 C until biochemical analyses.
| Study group | Role | What they receive |
|---|---|---|
| Patient with diabetes | 60 newly diagnosed type 2 diabetes Receives: Diagnostic Test: Blood sample | |
| Control | 60 non-diabetic control subjects Receives: Diagnostic Test: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose (FBG) levels
were assayed using glucose oxidase method.
Measured: three months
Fasting plasma insulin (FPI)
was assayed using Enzyme-Linked Immunosorbent Assay kits i.e ELISA
Measured: three months
HOMA-IR index
HOMA-IR index which is defined as fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 if fasting blood glucose is expressed in mass units (mg/dl).
Measured: three months
plasma IL-34
human plasma IL-34 was assayed using sandwich enzyme immunoassay technique
Measured: Three months
serum visfatin
serum visfatin concentrations enzyme- immunoassay kit
Measured: Three Months
IRAPe
extracellular part of insulin regulated aminopeptidase (IRAPe) level was determined using sandwich enzyme immunoassay technique
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start19 Jan 2019
- Primary completion30 Jun 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Tarek Mostafa, Ass Prof., Study chair, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107259
- Sponsor's protocol ID
- IRAPe, Irisin and IL-34
- Status last verified
- Jul 2020
- First submitted
- 25 Sep 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang EJ, Lee SK, Song YS, Jang YJ, Park HS, Hong JP, Ko AR, Kim DY, Kim JH, Lee YJ, Heo YS. IL-34 is associated with obesity, chronic inflammation, and insulin resistance. J Clin Endocrinol Metab. 2014 Jul;99(7):E1263-71. doi: 10.1210/jc.2013-4409. Epub 2014 Apr 8.
PubMed 24712570Sesti G, Andreozzi F, Fiorentino TV, Mannino GC, Sciacqua A, Marini MA, Perticone F. High circulating irisin levels are associated with insulin resistance and vascular atherosclerosis in a cohort of nondiabetic adult subjects. Acta Diabetol. 2014 Oct;51(5):705-13. doi: 10.1007/s00592-014-0576-0. Epub 2014 Mar 12.
PubMed 24619655Mostafa TM, El-Gharbawy NM, Werida RH. Circulating IRAPe, Irisin, and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes. Clin Ther. 2021 Jul;43(7):e230-e240. doi: 10.1016/j.clinthera.2021.05.003. Epub 2021 Jun 5.
PubMed 34103176
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating IRAPe, Irisin and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04107259
- Acronym / sponsor ID
- IRAPe, Irisin and IL-34
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, IL-34, Irisin, IRAPe, Visfatin, Insulin resistance, HOMA-IR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 27 Sep 2019 (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.
Aim: This study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (IRAPe), IL-34, Irisin, and Visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus.
Methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio.
Detailed description
Aim: This study aimed to evaluate the role of extracellular part of insulin regulated aminopeptidase (IRAPe), IL-34, Irisin, and Visfatin in the development of insulin resistance in patients with type 2 diabetes mellitus.
Methods: parallel study enrolled 60 non-diabetic control subjects and 60 newly-diagnosed type 2 diabetics, matched for age, body mass index and sex ratio. Anthropometric parameters, blood glucose, fasting plasma insulin, insulin resistance index (HOMA-IR), IL34, Irisin, IRAPe, Visfatin and glycated hemoglobin were assessed.
Conclusion: IL-34 and Visfatin levels were significantly increased, while both Irisin and IRAPe levels were significantly decreased in patients with type 2 diabetes. Theses aforementioned parameters were significantly correlated with insulin resistance. These findings indicate that, IL-34, Irisin and IRAPe may play a vital role in T2DM and in diabetes associated insulin resistance. Additionally, the investigator's findings proposed that, IRAPe may be a useful and direct marker for detection of insulin resistance state.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with diabetes | – | Diagnostic Test: Blood sample60 newly diagnosed type 2 diabetes |
| Control | – | Diagnostic Test: Blood sample60 non-diabetic control subjects |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes mellitus were diagnosed according to the criteria of the World Health Organization. All individuals included in this study were adult Middle-Eastern Egyptian citizens and were subjected to full medical history and physical examination by hospital physicians.
Key inclusion criteria (1 listed)
- newly diagnosed type 2 diabetes and non-diabetic control subjects from 35 to 65 years old were enrolled in this study.
Key exclusion criteria (1 listed)
- individuals with inflammatory diseases, Cushing's syndrome, thyroid disorders, infectious diseases, cancers, hepatic diseases and renal impairment. Subjects on insulin or other medications that could affect glucose metabolism or pro-inflammatory cytokines assessment (Glucocorticoids, beta-Adrenergic agonists, Thiazides, etc.....) were also excluded from study
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 |
|---|---|---|
| Blood sampleTen ml of venous blood was collected from all participants in the early morning after an overnight 12 hour fast by venipuncture of the antecubital vein into sterile tubes. Plasma and sera were separated immediately and were stored at -70 C until biochemical analyses. | Diagnostic test | Control, Patient with diabetes |
Primary outcome
Fasting blood glucose (FBG) levels
Time frame: three months
were assayed using glucose oxidase method.
Fasting plasma insulin (FPI)
Time frame: three months
was assayed using Enzyme-Linked Immunosorbent Assay kits i.e ELISA
HOMA-IR index
Time frame: three months
HOMA-IR index which is defined as fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 if fasting blood glucose is expressed in mass units (mg/dl).
plasma IL-34
Time frame: Three months
human plasma IL-34 was assayed using sandwich enzyme immunoassay technique
serum visfatin
Time frame: Three Months
serum visfatin concentrations enzyme- immunoassay kit
IRAPe
Time frame: Three months
extracellular part of insulin regulated aminopeptidase (IRAPe) level was determined using sandwich enzyme immunoassay technique
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 29 Jul 2020.
- Results publication: PubMed 24712570Chang EJ, Lee SK, Song YS, Jang YJ, Park HS, Hong JP, Ko AR, Kim DY, Kim JH, Lee YJ, Heo YS. IL-34 is associated with obesity, chronic inflammation, and insulin resistance. J Clin Endocrinol Metab. 2014 Jul;99(7):E1263-71. doi: 10.1210/jc.2013-4409. Epub 2014 Apr 8.
- Results publication: PubMed 24619655Sesti G, Andreozzi F, Fiorentino TV, Mannino GC, Sciacqua A, Marini MA, Perticone F. High circulating irisin levels are associated with insulin resistance and vascular atherosclerosis in a cohort of nondiabetic adult subjects. Acta Diabetol. 2014 Oct;51(5):705-13. doi: 10.1007/s00592-014-0576-0. Epub 2014 Mar 12.
- Derived from this study: PubMed 34103176Mostafa TM, El-Gharbawy NM, Werida RH. Circulating IRAPe, Irisin, and IL-34 in Relation to Insulin Resistance in Patients With Type 2 Diabetes. Clin Ther. 2021 Jul;43(7):e230-e240. doi: 10.1016/j.clinthera.2021.05.003. Epub 2021 Jun 5.
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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.
Tarek Mostafa, Ass Prof. study chair
Tanta University
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 Type2 Diabetes Mellitus, run by Damanhour University at 1 site in Egypt.
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 1 inclusion and 1 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 29 Jul 2020. 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 Egypt. 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?
Fasting blood glucose (FBG) levels (time frame: three months). The study lists 6 primary outcomes in all. 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 NCT04107259, which also lists 3 linked publications.
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 29 Jul 2020.