Effects of Testosterone and Fat Utilization

NCT ID: NCT03289559

Last Updated: 2017-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2014-01-01

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.

Conditions

Healthy; Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

GnRH antagonist + Placebo Gel

Group Type: PLACEBO_COMPARATOR

GnRH antagonist

Intervention Type: DRUG

Aromatase Inhibitors

Intervention Type: DRUG

GnRH antagonist + Testosterone Gel

Group Type: ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type: DRUG

Aromatase Inhibitors

Intervention Type: DRUG

Testosterone gel

Intervention Type: DRUG

Interventions

GnRH antagonist

Intervention Type: DRUG

Aromatase Inhibitors

Intervention Type: DRUG

Testosterone gel

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Bessesen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

Rynders CA, Schmidt SL, Bergouignan A, Horton TJ, Bessesen DH. Effects of short-term sex steroid suppression on dietary fat storage patterns in healthy males. Physiol Rep. 2018 Jan;6(2):e13533. doi: 10.14814/phy2.13533.

Reference Type: DERIVED

PMID: 29380951 (View on PubMed)

Other Identifiers

06-0010

Identifier Type: -

Identifier Source: org_study_id