ObesityNCT04133896
Circulating IL-6, Clusterin and Irisin in Obese Subjects
An observational study of Obesity, run by Rehab Werida at 1 site in Egypt.
Trial summary
evaluate the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and their sexual dimorphism also identify the association of IL-6, clusterin and irisin with insulin resistance. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Obesity
- What is being tested?
- IL-6, Clusterin, Irisin Level
- How many people
- 176 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 30 Jun 2019
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects included in the study were classified according to their sex into two main group the male group and the female group. The male group contained 88 men which subdivided according to the BMI into the following groups; group 1 (22 lean men), group 2 (22 class I obese men), group 3 (22class II obese men), and group 4 (22 class III obese men). The female group contained 88 adult women which sub-classified according to BMI into the following subgroups; group 1 (22 lean women), group 2 (22 class I obese women), group 3 (22 class II obese women), and group 4 (22 class III obese women).
Who may be able to join
- Healthy Female and Male
- Age matched adult non-diabetic non-smoker males and females'
Who cannot join
- smokers, subjects with a history of diabetes mellitus, liver, renal, thyroid, inflammatory diseases, and females on contraceptives pills. Patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, anti-hyperlipidemics, non-selective beta blockers, thiazides, etc.) and subjects with organic causes of obesity were also excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating IL-6, Clusterin and Irisin in Obese Subjects With Different Grades of Obesity: Association With Insulin Resistance and Sexual Dimorphism
evaluate the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and their sexual dimorphism also identify the association of IL-6, clusterin and irisin with insulin resistance.
Read the detailed description
Aim: Firstly, this study aimed at assessing the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and evaluating their sexual dimorphism and secondly evaluate the association of IL-6, clusterin and irisin with insulin resistance.
Method: This study was conducted on 176 non-diabetic subjects of both sexes. Participants were classified according to their sex into two groups; the male and female groups. The male group (88 men) was classified according to BMI into; group 1 (22 lean men), group 2 (22 class I obese men), group 3 (22 class II obese men), and group 4 (22 class III obese men). The female group (88 women) was also classified according to BMI exactly as the male group. Fasting blood glucose, fasting insulin, lipid panel, serum IL-6, clusterin and irisin levels were measured. One-way analysis of variance followed by Tukey's as post hoc test was used for comparison of variables.
- Conditions
- Obesity
- Being tested
- IL-6, Clusterin, Irisin Level
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-6, Clusterin, Irisin LevelDiagnostic test
Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Male | group 1 (22 lean men), Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level | |
| Group 2 Male | group 2 (22 class I obese men), Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level | |
| Group 3 Male | group 3 (22class II obese men), Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level | |
| Group 4 Male | group 4 (22 class III obese men). Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level | |
| Group 1 Female | group 1 (22 lean women), Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level | |
| Group 2 Female | group 2 (22 class I obese women), Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level | |
| Group 3 Female | group 3 (22 class II obese women), Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level | |
| Group 4 Female | group 4 (22 class III obese women). Receives: Diagnostic Test: IL-6, Clusterin, Irisin Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
by homeostasis insulin resistance index (fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 )
Measured: 18 months
IL- 6
blood level of IL-6
Measured: 18 Months
Clusterin
blood level of Clusterin
Measured: 18 Months
Irisin
blood level of Irisin
Measured: 18 Months
Lipid profile
Plasma triglycerides and total cholesterol were measured by enzymatic colorimetric method. High-density lipoprotein cholesterol (HDL-C) was measured by precipitation method. Low density lipoprotein cholesterol (LDL-C) was calculated using the Friedewald formula
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Feb 2018
- Primary completion1 Jun 2019
- Study completion30 Jun 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 ObesityStudies 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Lecturer, Principal investigator, Damanhour University, Faculty of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133896
- Sponsor's protocol ID
- Obesity and IR
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gouni-Berthold I, Berthold HK, Huh JY, Berman R, Spenrath N, Krone W, Mantzoros CS. Effects of lipid-lowering drugs on irisin in human subjects in vivo and in human skeletal muscle cells ex vivo. PLoS One. 2013 Sep 2;8(9):e72858. doi: 10.1371/journal.pone.0072858. eCollection 2013.
PubMed 24023786Baralla A, Sotgiu E, Deiana M, Pasella S, Pinna S, Mannu A, Canu E, Sotgiu G, Ganau A, Zinellu A, Sotgia S, Carru C, Deiana L. Plasma Clusterin and Lipid Profile: A Link with Aging and Cardiovascular Diseases in a Population with a Consistent Number of Centenarians. PLoS One. 2015 Jun 15;10(6):e0128029. doi: 10.1371/journal.pone.0128029. eCollection 2015.
PubMed 26076476van Greevenbroek MM, Schalkwijk CG, Stehouwer CD. Obesity-associated low-grade inflammation in type 2 diabetes mellitus: causes and consequences. Neth J Med. 2013 May;71(4):174-87.
PubMed 23723111
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating IL-6, Clusterin and Irisin in Obese Subjects With Different Grades of Obesity: Association With Insulin Resistance and Sexual Dimorphism
- ClinicalTrials.gov ID
- NCT04133896
- Acronym / sponsor ID
- Obesity and IR
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Oct 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.
evaluate the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and their sexual dimorphism also identify the association of IL-6, clusterin and irisin with insulin resistance.
Detailed description
Aim: Firstly, this study aimed at assessing the circulating levels of IL-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and evaluating their sexual dimorphism and secondly evaluate the association of IL-6, clusterin and irisin with insulin resistance.
Method: This study was conducted on 176 non-diabetic subjects of both sexes. Participants were classified according to their sex into two groups; the male and female groups. The male group (88 men) was classified according to BMI into; group 1 (22 lean men), group 2 (22 class I obese men), group 3 (22 class II obese men), and group 4 (22 class III obese men). The female group (88 women) was also classified according to BMI exactly as the male group. Fasting blood glucose, fasting insulin, lipid panel, serum IL-6, clusterin and irisin levels were measured. One-way analysis of variance followed by Tukey's as post hoc test was used for comparison of variables.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1 Male | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 1 (22 lean men), |
| Group 2 Male | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 2 (22 class I obese men), |
| Group 3 Male | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 3 (22class II obese men), |
| Group 4 Male | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 4 (22 class III obese men). |
| Group 1 Female | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 1 (22 lean women), |
| Group 2 Female | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 2 (22 class I obese women), |
| Group 3 Female | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 3 (22 class II obese women), |
| Group 4 Female | – | Diagnostic Test: IL-6, Clusterin, Irisin Levelgroup 4 (22 class III obese women). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects included in the study were classified according to their sex into two main group the male group and the female group. The male group contained 88 men which subdivided according to the BMI into the following groups; group 1 (22 lean men), group 2 (22 class I obese men), group 3 (22class II obese men), and group 4 (22 class III obese men). The female group contained 88 adult women which sub-classified according to BMI into the following subgroups; group 1 (22 lean women), group 2 (22 class I obese women), group 3 (22 class II obese women), and group 4 (22 class III obese women).
Key inclusion criteria (2 listed)
- Healthy Female and Male
- Age matched adult non-diabetic non-smoker males and females'
Key exclusion criteria (1 listed)
- smokers, subjects with a history of diabetes mellitus, liver, renal, thyroid, inflammatory diseases, and females on contraceptives pills. Patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, anti-hyperlipidemics, non-selective beta blockers, thiazides, etc.) and subjects with organic causes of obesity were also excluded from this 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 |
|---|---|---|
| IL-6, Clusterin, Irisin LevelBlood samples to determine levels of Circulating IL-6, Clusterin and Irisin | Diagnostic test | Group 1 Female, Group 1 Male, Group 2 Female, Group 2 Male, Group 3 Female, Group 3 Male, Group 4 Female, Group 4 Male |
Primary outcome
insulin resistance
Time frame: 18 months
by homeostasis insulin resistance index (fasting insulin (μIU/ml) times fasting glucose (mg/L) divided by 405 )
IL- 6
Time frame: 18 Months
blood level of IL-6
Clusterin
Time frame: 18 Months
blood level of Clusterin
Irisin
Time frame: 18 Months
blood level of Irisin
Lipid profile
Time frame: 18 Months
Plasma triglycerides and total cholesterol were measured by enzymatic colorimetric method. High-density lipoprotein cholesterol (HDL-C) was measured by precipitation method. Low density lipoprotein cholesterol (LDL-C) was calculated using the Friedewald formula
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 22 Oct 2019.
- Results publication: PubMed 24023786Gouni-Berthold I, Berthold HK, Huh JY, Berman R, Spenrath N, Krone W, Mantzoros CS. Effects of lipid-lowering drugs on irisin in human subjects in vivo and in human skeletal muscle cells ex vivo. PLoS One. 2013 Sep 2;8(9):e72858. doi: 10.1371/journal.pone.0072858. eCollection 2013.
- Results publication: PubMed 26076476Baralla A, Sotgiu E, Deiana M, Pasella S, Pinna S, Mannu A, Canu E, Sotgiu G, Ganau A, Zinellu A, Sotgia S, Carru C, Deiana L. Plasma Clusterin and Lipid Profile: A Link with Aging and Cardiovascular Diseases in a Population with a Consistent Number of Centenarians. PLoS One. 2015 Jun 15;10(6):e0128029. doi: 10.1371/journal.pone.0128029. eCollection 2015.
- Results publication: PubMed 23723111van Greevenbroek MM, Schalkwijk CG, Stehouwer CD. Obesity-associated low-grade inflammation in type 2 diabetes mellitus: causes and consequences. Neth J Med. 2013 May;71(4):174-87.
- 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.
Rehab H Werida, Lecturer principal investigator
Damanhour University, Faculty of Pharmacy
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 Obesity, run by Rehab Werida 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 2 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 22 Oct 2019. 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?
insulin resistance (time frame: 18 months). The study lists 5 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 NCT04133896, 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 22 Oct 2019.