Effects of Testosterone and Fat Utilization

Healthy Clinical Trial

Official title:

Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289559
• Other study ID #: 06-0010
• Status: Completed
• Phase: N/A
• First received: September 18, 2017
• Last updated: September 19, 2017
• Start date: January 1, 2006
• Est. completion date: January 1, 2014

Study information

• Verified date: September 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evidence is accumulating that there are sex differences in energy and substrate metabolism. The positive or negative consequences of such metabolic differences between men and women need to be evaluated with respect to health outcomes. The importance of aberrant lipid metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes understanding the distinction between "normal" vs aberrant critical to future treatment and prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism and substrate oxidation in non-obese, healthy individuals, have been consistently observed. In addition, distinct differences in men and women exist in the distribution of body fat, with men typically having greater central adiposity than women. Accumulation of fat in the abdomen is associated with an increased risk for metabolic abnormalities such as hyperlipidemia and insulin resistance. In the current study, therefore, the role of testosterone in determining the sex differences in catecholamine mediated substrate metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots will be addressed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 1, 2014
• Est. primary completion date: January 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• normal weight (BMI of 23-29.9 kg/m2)

• not be highly trained (< 5hrs of moderate intensity, planned exercise per week).

Exclusion Criteria:

• Patients will be excluded if they have one or more of the following out-of-range values measured on a fasting blood sample:

• glucose <65 or > 110 mg/dl,

• insulin > 20 uU/ml,

• thyroid stimulating hormone <0.5 or >5.0 uU/ml,

• growth hormone >2.5 ng/ml.

• Subjects who may be:

• anemic (hemoglobin < 14.5 g/dl men ),

• have abnormal liver function tests:

• alanine amino transferase > 47 U/l,

• aspartate aminotransferase, > 47 U/l,

• alkaline phosphatase <39 or >117 U/l) or

• creatinine (<0.6 or >1.1 mg/dl).

Related Conditions & MeSH terms

• Healthy
• Volunteers

Intervention

Drug:
• GnRH antagonist

• Aromatase Inhibitors

• Testosterone gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary fat tracer for storage of meal derived fatty acids	50 uCi of [1-14C] oleic acid administered with an inpatient test meal	4 weeks