Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men

Obesity Clinical Trial

Official title:

Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03724825
• Other study ID #: Adropin in obese men
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: January 7, 2020

Study information

• Verified date: February 2022
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 7, 2020
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Diabetes mellitus Hypertension Heart failure Kidney disease Smoking

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity

Intervention

Diagnostic Test:
• 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
• Total testosterone
blood samples will be collected after 10 hours fasting
• Adropin
blood samples will be collected after 10 hours fasting
• Adiponectin
blood samples will be collected after 10 hours fasting

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

Ghoshal S, Stevens JR, Billon C, Girardet C, Sitaula S, Leon AS, Rao DC, Skinner JS, Rankinen T, Bouchard C, Nuñez 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Primary	changes in total testosterone levels	expected lower testosterone levels in obese men compared to normal men	6 months
Primary	changes in adropin level	expected lower adropin levels in obese men compared to normal men	6 months
Primary	changed in adiponectin levels	expected lower adiponectin level in obese men compared to normal men	6 months
Primary	correlation between adropin and testosterone		6 months
Primary	correlation between adropin and adiponectin		6 months