Effects of Testosterone and Fat Utilization

NCT03289559 | Completed DMC

• 1 other identifier: 06-0010
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control

NO INTERVENTION

GnRH antagonist + Placebo Gel

PLACEBO COMPARATOR

Drug: GnRH antagonist; Drug: Aromatase Inhibitors

GnRH antagonist + Testosterone Gel

ACTIVE COMPARATOR

Drug: GnRH antagonist; Drug: Aromatase Inhibitors; Drug: Testosterone gel

Interventions

GnRH antagonist DRUG

GnRH antagonist + Placebo Gel; GnRH antagonist + Testosterone Gel

Aromatase Inhibitors DRUG

GnRH antagonist + Placebo Gel; GnRH antagonist + Testosterone Gel

Testosterone gel DRUG

GnRH antagonist + Testosterone Gel

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• normal weight (BMI of 23-29.9 kg/m2)
• not be highly trained (\< 5hrs of moderate intensity, planned exercise per week).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Related Publications (1)

• 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.

  PMID: 29380951 DERIVED

MeSH Terms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; Aromatase Inhibitors

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Daniel Bessesen, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 21, 2017
• Study Start: January 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2014
• Last Updated: September 21, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share