Effects of Testosterone and Fat Utilization

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

GnRh antagonist

Drug

Aromatase Inhibitors

Drug

Testosterone gel

Drug

Primary outcomes

Dietary fat tracer for storage of meal derived fatty acids

Time frame: 4 weeks

50 uCi of [1-14C] oleic acid administered with an inpatient test meal

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2014
First posted: Sep 21, 2017
Registry last updated: Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed