ObesityNCT03724825
Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men
An observational study of Obesity and Dyslipidemias, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Obesity is associated with low testosterone in men and with dyslipidemia. Adropin hormone is negatively correlated with body mass index and is associated with dyslipidemia. correlation between adropin and testosterone will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dyslipidemias
- What is being tested?
- lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL)), Total testosterone and Adropin
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 7 Jan 2020
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: obese and normal weight men from 18 years to 50 years
Who may be able to join
- Age from 18 years to 50 years. Clinically free except from obesity
Who cannot join
- Diabetes mellitus Hypertension Heart failure Kidney disease Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is associated with low testosterone in men and with dyslipidemia. Adropin hormone is negatively correlated with body mass index and is associated with dyslipidemia.
correlation between adropin and testosterone will be evaluated.
Read the detailed description
Obesity, a worldwide epidemic is associated with multiple adverse health outcome as diabetes mellitus, hypertension and cardiovascular diseases caused mainly by dyslipidemia linked to obesity. Low testosterone levels in obese men were found associated with dyslipidemia.
Adropin is a new metabolic hormone that was first isolated in liver and brain tissues, It was observed that mice fed on a high-fat diet (HFD) had a rapid increase in adropin expression compared to control values. In human also, adropin levels were negatively correlated with body mass index (BMI) and were associated with dyslipidemia.
Adiponectin is a protein that is mainly produced by white adipose tissue and has an important role in lipid metabolism. Serum adiponectin concentrations were decreased in obese compared to normal weight men and significantly correlated with testosterone level.
- Conditions
- Obesity, Dyslipidemias
- Being tested
- lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL)), Total testosterone, Adropin, Adiponectin
- Keywords
- Adropin, adiponectin, testosterone, obese men
- Medical subject headings
- Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL))Diagnostic test
blood samples will be collected after 10 hours fasting
Total testosteroneDiagnostic test
blood samples will be collected after 10 hours fasting
AdropinDiagnostic test
blood samples will be collected after 10 hours fasting
AdiponectinDiagnostic test
blood samples will be collected after 10 hours fasting
| Study group | Role | What they receive |
|---|---|---|
| obese men | Adult obese men (BMI ≥ 30 kg/m2) Receives: Diagnostic Test: lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL)); Diagnostic Test: Total testosterone; Diagnostic Test: Adropin; Diagnostic Test: Adiponectin | |
| normal men | normal weight men (18.5 ≤ BMI < 25 kg/m2 ) Receives: Diagnostic Test: lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL)); Diagnostic Test: Total testosterone; Diagnostic Test: Adropin; Diagnostic Test: Adiponectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in lipid profile (TC, TG, LDL, HDL) levels
expected higher TC, TG, LDl levels and lower HDL levels in obese men compared to normal
Measured: 6 months
changes in total testosterone levels
expected lower testosterone levels in obese men compared to normal men
Measured: 6 months
changes in adropin level
expected lower adropin levels in obese men compared to normal men
Measured: 6 months
changed in adiponectin levels
expected lower adiponectin level in obese men compared to normal men
Measured: 6 months
correlation between adropin and testosterone
Measured: 6 months
correlation between adropin and adiponectin
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Dec 2018
- Primary completion29 Nov 2019
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdel-mageed Muhammed, Aswan University Hospital
- Investigators
- Asmaa Abdelmageed Muhammed, Assistant lecturer, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724825
- Sponsor's protocol ID
- Adropin in obese men
- Status last verified
- Feb 2022
- First submitted
- 29 Oct 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Canguven O, Talib RA, El Ansari W, Yassin DJ, Salman M, Al-Ansari A. Testosterone therapy has positive effects on anthropometric measures, metabolic syndrome components (obesity, lipid profile, Diabetes Mellitus control), blood indices, liver enzymes, and prostate health indicators in elderly hypogonadal men. Andrologia. 2017 Dec;49(10). doi: 10.1111/and.12768. Epub 2017 Mar 10.
PubMed 28295504Ghoshal S, Stevens JR, Billon C, Girardet C, Sitaula S, Leon AS, Rao DC, Skinner JS, Rankinen T, Bouchard C, Nunez MV, Stanhope KL, Howatt DA, Daugherty A, Zhang J, Schuelke M, Weiss EP, Coffey AR, Bennett BJ, Sethupathy P, Burris TP, Havel PJ, Butler AA. Adropin: An endocrine link between the biological clock and cholesterol homeostasis. Mol Metab. 2018 Feb;8:51-64. doi: 10.1016/j.molmet.2017.12.002. Epub 2017 Dec 30.
PubMed 29331507Yosaee S, Khodadost M, Esteghamati A, Speakman JR, Shidfar F, Nazari MN, Bitarafan V, Djafarian K. Metabolic Syndrome Patients Have Lower Levels of Adropin When Compared With Healthy Overweight/Obese and Lean Subjects. Am J Mens Health. 2017 Mar;11(2):426-434. doi: 10.1177/1557988316664074. Epub 2016 Aug 22.
PubMed 27550773Kim AY, Park YJ, Pan X, Shin KC, Kwak SH, Bassas AF, Sallam RM, Park KS, Alfadda AA, Xu A, Kim JB. Obesity-induced DNA hypermethylation of the adiponectin gene mediates insulin resistance. Nat Commun. 2015 Jul 3;6:7585. doi: 10.1038/ncomms8585.
PubMed 26139044Thomas S, Kratzsch D, Schaab M, Scholz M, Grunewald S, Thiery J, Paasch U, Kratzsch J. Seminal plasma adipokine levels are correlated with functional characteristics of spermatozoa. Fertil Steril. 2013 Apr;99(5):1256-1263.e3. doi: 10.1016/j.fertnstert.2012.12.022. Epub 2013 Jan 30.
PubMed 23375204Muhammed AA, Eid RMHM, Mohammed WS, Abdel-Fadeil MR. An association between adropin hormone and total testosterone in obese men: a case-control study. BMC Endocr Disord. 2022 Jul 27;22(1):192. doi: 10.1186/s12902-022-01102-7.
PubMed 35897011
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men
- ClinicalTrials.gov ID
- NCT03724825
- Acronym / sponsor ID
- Adropin in obese men
- Conditions
- Obesity, Dyslipidemias
- Keywords
- Adropin, adiponectin, testosterone, obese men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 30 Oct 2018 (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.
Obesity is associated with low testosterone in men and with dyslipidemia. Adropin hormone is negatively correlated with body mass index and is associated with dyslipidemia.
correlation between adropin and testosterone will be evaluated.
Detailed description
Obesity, a worldwide epidemic is associated with multiple adverse health outcome as diabetes mellitus, hypertension and cardiovascular diseases caused mainly by dyslipidemia linked to obesity. Low testosterone levels in obese men were found associated with dyslipidemia.
Adropin is a new metabolic hormone that was first isolated in liver and brain tissues, It was observed that mice fed on a high-fat diet (HFD) had a rapid increase in adropin expression compared to control values. In human also, adropin levels were negatively correlated with body mass index (BMI) and were associated with dyslipidemia.
Adiponectin is a protein that is mainly produced by white adipose tissue and has an important role in lipid metabolism. Serum adiponectin concentrations were decreased in obese compared to normal weight men and significantly correlated with testosterone level.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese men | – | Diagnostic Test: lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL)), Diagnostic Test: Total testosterone, Diagnostic Test: Adropin, Diagnostic Test: AdiponectinAdult obese men (BMI ≥ 30 kg/m2) |
| normal men | – | Diagnostic Test: lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL)), Diagnostic Test: Total testosterone, Diagnostic Test: Adropin, Diagnostic Test: Adiponectinnormal weight men (18.5 ≤ BMI < 25 kg/m2 ) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- obese and normal weight men from 18 years to 50 years
Key inclusion criteria (1 listed)
- Age from 18 years to 50 years. Clinically free except from obesity
Key exclusion criteria (1 listed)
- Diabetes mellitus Hypertension Heart failure Kidney disease Smoking
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 |
|---|---|---|
| lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL))blood samples will be collected after 10 hours fasting | Diagnostic test | normal men, obese men |
| Total testosteroneblood samples will be collected after 10 hours fasting | Diagnostic test | normal men, obese men |
| Adropinblood samples will be collected after 10 hours fasting | Diagnostic test | normal men, obese men |
| Adiponectinblood samples will be collected after 10 hours fasting | Diagnostic test | normal men, obese men |
Primary outcome
changes in lipid profile (TC, TG, LDL, HDL) levels
Time frame: 6 months
expected higher TC, TG, LDl levels and lower HDL levels in obese men compared to normal
changes in total testosterone levels
Time frame: 6 months
expected lower testosterone levels in obese men compared to normal men
changes in adropin level
Time frame: 6 months
expected lower adropin levels in obese men compared to normal men
changed in adiponectin levels
Time frame: 6 months
expected lower adiponectin level in obese men compared to normal men
correlation between adropin and testosterone
Time frame: 6 months
correlation between adropin and adiponectin
Time frame: 6 months
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 2 Mar 2022.
- Background: PubMed 28295504Canguven O, Talib RA, El Ansari W, Yassin DJ, Salman M, Al-Ansari A. Testosterone therapy has positive effects on anthropometric measures, metabolic syndrome components (obesity, lipid profile, Diabetes Mellitus control), blood indices, liver enzymes, and prostate health indicators in elderly hypogonadal men. Andrologia. 2017 Dec;49(10). doi: 10.1111/and.12768. Epub 2017 Mar 10.
- Background: PubMed 29331507Ghoshal S, Stevens JR, Billon C, Girardet C, Sitaula S, Leon AS, Rao DC, Skinner JS, Rankinen T, Bouchard C, Nunez MV, Stanhope KL, Howatt DA, Daugherty A, Zhang J, Schuelke M, Weiss EP, Coffey AR, Bennett BJ, Sethupathy P, Burris TP, Havel PJ, Butler AA. Adropin: An endocrine link between the biological clock and cholesterol homeostasis. Mol Metab. 2018 Feb;8:51-64. doi: 10.1016/j.molmet.2017.12.002. Epub 2017 Dec 30.
- Background: PubMed 27550773Yosaee S, Khodadost M, Esteghamati A, Speakman JR, Shidfar F, Nazari MN, Bitarafan V, Djafarian K. Metabolic Syndrome Patients Have Lower Levels of Adropin When Compared With Healthy Overweight/Obese and Lean Subjects. Am J Mens Health. 2017 Mar;11(2):426-434. doi: 10.1177/1557988316664074. Epub 2016 Aug 22.
- Background: PubMed 26139044Kim AY, Park YJ, Pan X, Shin KC, Kwak SH, Bassas AF, Sallam RM, Park KS, Alfadda AA, Xu A, Kim JB. Obesity-induced DNA hypermethylation of the adiponectin gene mediates insulin resistance. Nat Commun. 2015 Jul 3;6:7585. doi: 10.1038/ncomms8585.
- Background: PubMed 23375204Thomas S, Kratzsch D, Schaab M, Scholz M, Grunewald S, Thiery J, Paasch U, Kratzsch J. Seminal plasma adipokine levels are correlated with functional characteristics of spermatozoa. Fertil Steril. 2013 Apr;99(5):1256-1263.e3. doi: 10.1016/j.fertnstert.2012.12.022. Epub 2013 Jan 30.
- Derived from this study: PubMed 35897011Muhammed AA, Eid RMHM, Mohammed WS, Abdel-Fadeil MR. An association between adropin hormone and total testosterone in obese men: a case-control study. BMC Endocr Disord. 2022 Jul 27;22(1):192. doi: 10.1186/s12902-022-01102-7.
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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.
Asmaa Abdelmageed Muhammed, Assistant lecturer principal investigator
Aswan University Hospital
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 and Dyslipidemias, run by Aswan University Hospital 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 2 Mar 2022. 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?
changes in lipid profile (TC, TG, LDL, HDL) levels (time frame: 6 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 NCT03724825, which also lists 6 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 2 Mar 2022.