- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03724825
Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aswan, Egypt, 81528
- Aswan University hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Age from 18 years to 50 years. Clinically free except from obesity
Exclusion Criteria:
- Diabetes mellitus Hypertension Heart failure Kidney disease Smoking
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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obese men
Adult obese men (BMI ≥ 30 kg/m2)
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blood samples will be collected after 10 hours fasting
blood samples will be collected after 10 hours fasting
blood samples will be collected after 10 hours fasting
blood samples will be collected after 10 hours fasting
|
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normal men
normal weight men (18.5 ≤ BMI < 25 kg/m2 )
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blood samples will be collected after 10 hours fasting
blood samples will be collected after 10 hours fasting
blood samples will be collected after 10 hours fasting
blood samples will be collected after 10 hours fasting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in lipid profile (TC, TG, LDL, HDL) levels
Time Frame: 6 months
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expected higher TC, TG, LDl levels and lower HDL levels in obese men compared to normal
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6 months
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changes in total testosterone levels
Time Frame: 6 months
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expected lower testosterone levels in obese men compared to normal men
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6 months
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changes in adropin level
Time Frame: 6 months
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expected lower adropin levels in obese men compared to normal men
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6 months
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changed in adiponectin levels
Time Frame: 6 months
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expected lower adiponectin level in obese men compared to normal men
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6 months
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correlation between adropin and testosterone
Time Frame: 6 months
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6 months
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correlation between adropin and adiponectin
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asmaa Abdelmageed Muhammed, Assistant lecturer, Aswan University hospital
Publications and helpful links
General 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.
- Ghoshal 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.
- Yosaee 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.
- Kim 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.
- Thomas 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.
- Muhammed 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adropin in obese men
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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