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Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men

NCT00365794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-08-26

Study results available
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Summary

A. HYPOTHESES: In older men low testosterone levels, abdominal obesity and elevated fasting insulin who are at risk for the cardiovascular complications such as heart attack and stroke.

1. Supplemental testosterone will decrease abdominal adipose tissue and hepatic fat) and appendicular fat and intramyocellular lipid in peripheral muscles (IMCL).
2. Supplemental testosterone will improve insulin sensitivity by:

1. Decreasing hepatic glucose output (HGO), a measure of central insulin resistance
2. increasing peipheral glucose disposal (Rd), a measure of periperal insuln sensiivity
3. . Improving peripheral glucose disposal (Rd) by reducing IMCL
4. Increasing appendicular skeletal muscle mass

B. OBJECTIVES:

1. Primary Objective: To determine the effects of supplemental testosterone to achieve testosterone levels in the upper normal physiologic range on central adipose tissue (abdominal and hepatic fat) and peripheral skeletal muscle fat (appendicular fat and IMCL).
2. Secondary Objectives: To determine the effects of supplemental testosterone to achieve testosterone levels in the upper normal physiologic range:on central insulin sensitivity ( hepatic glucose output (\[HGO\]) and peripheral insulin sensitivity (glucose disposal (Rd)

Results of this study will provide greater understanding whether androgen therapy enhances insulin sensitivity by decreasing HGO, improving peripheral Rd and if these desired effects are achieved, whether they are due to reductions in abdominal fat or liver lipid, IMCL or effects of augmenting muscle mass per se.

Results will generate hypotheses to investigate cellular and molecular mechanisms of androgen effects in persons at risk for the Metabolic Syndrome.

Conditions

Interventions

DRUG

Topical testosterone gel 10 g/day

Testosterone gel therapy for 20 weeks

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Fred R Sattler, MD · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2013-12-31
Completion
2014-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365794 on ClinicalTrials.gov