Effects of Testosterone and Fat Utilization

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT03289559

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: GnRH antagonist Drug: Aromatase Inhibitors Drug: Testosterone gel	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Testosterone Effects on Systemic Lipolysis and Whole Body Lipid Utilization

Actual Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control
Placebo Comparator: GnRH antagonist + Placebo Gel	Drug: GnRH antagonist Drug: Aromatase Inhibitors
Active Comparator: GnRH antagonist + Testosterone Gel	Drug: GnRH antagonist Drug: Aromatase Inhibitors Drug: Testosterone gel

Arm

Intervention/Treatment

No Intervention: Control

Placebo Comparator: GnRH antagonist + Placebo Gel

Drug: GnRH antagonist

Drug: Aromatase Inhibitors

Active Comparator: GnRH antagonist + Testosterone Gel

Drug: GnRH antagonist

Drug: Aromatase Inhibitors

Drug: Testosterone gel

Outcome Measures

Primary Outcome Measures

Dietary fat tracer for storage of meal derived fatty acids [4 weeks]
50 uCi of [1-14C] oleic acid administered with an inpatient test meal

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Daniel Bessesen, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT03289559

Other Study ID Numbers:

06-0010

First Posted:

Sep 21, 2017

Last Update Posted:

Sep 21, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Testosterone

Aromatase Inhibitors

Study Results

No Results Posted as of Sep 21, 2017