Clinical trial NCT03724825: Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men
Official title: Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Dyslipidemias
Keywords: Adropin
adiponectin
testosterone
obese men
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese and normal weight men from 18 years to 50 years

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Age from 18 years to 50 years. Clinically free except from obesity

Exclusion Criteria:

* Diabetes mellitus Hypertension Heart failure Kidney disease Smoking

Primary outcomes:
measure: changes in lipid profile (TC, TG, LDL, HDL) levels
timeFrame: 6 months
measure: changes in total testosterone levels
timeFrame: 6 months
measure: changes in adropin level
timeFrame: 6 months
measure: changed in adiponectin levels
timeFrame: 6 months
measure: correlation between adropin and testosterone
timeFrame: 6 months
measure: correlation between adropin and adiponectin
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University Hospital
name: Asmaa Abdelmageed Muhammed, Assistant lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.