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Trial record 10 of 127 for:    "ACDC"

Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men

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ClinicalTrials.gov Identifier: NCT03724825
Recruitment Status : Not yet recruiting
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Asmaa Abdel-mageed Muhammed, Aswan University Hospital

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.


Condition or disease Intervention/treatment
Obesity Dyslipidemias 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

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 : Observational
Estimated Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Correlation of Serum Adropin to Testosterone and Adiponectin in Obese Men
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
obese men
Adult obese men (BMI ≥ 30 kg/m2)
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

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

Diagnostic Test: Adropin
blood samples will be collected after 10 hours fasting

Diagnostic Test: Adiponectin
blood samples will be collected after 10 hours fasting

normal men
normal weight men (18.5 ≤ BMI < 25 kg/m2 )
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

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

Diagnostic Test: Adropin
blood samples will be collected after 10 hours fasting

Diagnostic Test: Adiponectin
blood samples will be collected after 10 hours fasting




Primary Outcome Measures :
  1. 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

  2. changes in total testosterone levels [ Time Frame: 6 months ]
    expected lower testosterone levels in obese men compared to normal men

  3. changes in adropin level [ Time Frame: 6 months ]
    expected lower adropin levels in obese men compared to normal men

  4. changed in adiponectin levels [ Time Frame: 6 months ]
    expected lower adiponectin level in obese men compared to normal men

  5. correlation between adropin and testosterone [ Time Frame: 6 months ]
  6. correlation between adropin and adiponectin [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
obese and normal weight men from 18 years to 50 years
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724825


Contacts
Contact: Asmaa Abdelmageed Muhammed, Assistant lecturer 01098548122 asmaa.ali@med.aswu.edu.eg

Locations
Egypt
Aswan University Hospital Not yet recruiting
Aswan, Egypt, 81528
Contact: Asmaa Abdelmageed Muhammed, Assistant lecturer    01098548122    asmaa.ali@med.aswu.edu.eg   
Principal Investigator: Mahmoud Rafaat Abdelfadeil, Professor         
Principal Investigator: Rania Mohammed Hassan, lecturer         
Principal Investigator: Wafaa Salah Mohammed, lecturer         
Sponsors and Collaborators
Aswan University Hospital
Investigators
Principal Investigator: Asmaa Abdelmageed Muhammed, Assistant lecturer Aswan University Hospital

Publications:

Responsible Party: Asmaa Abdel-mageed Muhammed, Assistant lecturer, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03724825     History of Changes
Other Study ID Numbers: Adropin in obese men
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Asmaa Abdel-mageed Muhammed, Aswan University Hospital:
Adropin
adiponectin
testosterone
obese men

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents