CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Topical testosterone gel 10 g/daydrug
Likely dose
Topical testosterone gel 10 g/dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00365794
NCT00365794Phase 2Completed

Investigator Initiated Study of the Effects of Androgen Therapy on Carbohydrate and Lipid Metabolism In Elderly Men

University of Southern California·interventional·Posted Aug 17, 2006·Updated Aug 26, 2019

In Brief

A Phase 2 clinical trial evaluating Topical testosterone gel 10 g/day for Aging and 3 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2006
Enrollment StartAug 1, 2006
Primary CompletionDec 1, 2013
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.9 years ago

Interventions

Topical testosterone gel 10 g/daydrug

Testosterone gel therapy for 20 weeks