Trial · NCT00365794
Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
NCT00365794, Phase 2, Completed, University of Southern California; results first posted 2019-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men. Trials, record NCT00365794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00365794
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
- NCT number
- NCT00365794
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- University of Southern California
- Conditions
- Aging, Obesity, Insulin Resistance, Hypogonadism
- Interventions
- Topical testosterone gel 10 g/day
- First posted
- 2006-08-17
- Last updated
- 2019-08-26
- Results first posted
- 2019-08-26
- Limitations and caveats
- The primary limitation of this small pilot study is that it does not have a control group.~It is also likely under-powered and thus unable to show significance differences for some measurements.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Total Mass and Regional Adipose Adiposiy | Baseline to 20 weeks | Change in total body mass, total fat mass, trunk fat, and extremity fat |
| Primary | Change in Hepatic Lipid | Baseline to week 20 | Amount of liver fat is highly predictive of insulin resistance. Hepatic fat is measured by MR spectroscopy and adjusted for H2O and results are reported as ratio of these two. |
| Primary | Intramyocellular Lipid (IMCL) | Baseline to week 20 | IMCL is quantified by MR spectroscopy of the anterior tibialis muscle of the leg. The value is adjusted for creatine and reported as a ratio |
| Secondary | Change in Percentage of Total Body Fat | Baseline and 20 weeks | Percentage of total body fat is quantified by DEXA scanning |
| Secondary | Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO]) | Baseline and 20 weeks | In the final analysis, total and regional carbohydrate metabolism during a 2-hr hyperinsulinemic euglycemic clamp (peripheral glucose disposal \[Rd\],hepatic glucose output \[HGO\]) were analyzed by mass transfer of glucose during both stages of the clamp relative to insulin levels. |
| Secondary | Change in Skeletal Muscle Mass by DEXA | Baselne to 20 weeks | Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle. |
| Secondary | Plasma Lipids | Baseline to week 20 | |
| Secondary | Change in HOMA-IR | Baseline to week 20 | HOMA-IR is a measure of insulin resistance |
| Secondary | Change in Basal FFAs in Plasma | Baseline to week 20 | FFA (plasma free fatty acids) are measure of lipid metabolism |
| Secondary | Change in Plasma Free Fatty Acids During Glucose Clamp | Baseline to 20 weeks |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Total Mass and Regional Adipose Adiposiy | Baseline to 20 weeks | Data for one participant was not available | kilograms | MEDIAN |
| PRIMARY | Change in Hepatic Lipid | Baseline to week 20 | Data not available for one subject | ratio | MEDIAN |
| PRIMARY | Intramyocellular Lipid (IMCL) | Baseline to week 20 | data not available for 5 subjects | ratio | MEDIAN |
| SECONDARY | Change in Percentage of Total Body Fat | Baseline and 20 weeks | Data not available for one subject | percentage of total body fat | MEDIAN |
| SECONDARY | Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO]) | Baseline and 20 weeks | dL/min per μU/mL | MEDIAN | |
| SECONDARY | Change in Skeletal Muscle Mass by DEXA | Baselne to 20 weeks | kilograms | MEDIAN | |
| SECONDARY | Plasma Lipids | Baseline to week 20 | mg/dL | MEDIAN | |
| SECONDARY | Change in HOMA-IR | Baseline to week 20 | microU/L) x fasting glucose (nmol/L)/22 | MEDIAN | |
| SECONDARY | Change in Basal FFAs in Plasma | Baseline to week 20 | mEq/L | MEDIAN | |
| SECONDARY | Change in Plasma Free Fatty Acids During Glucose Clamp | Baseline to 20 weeks | grams | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Total Mass and Regional Adipose Adiposiy | Single Arm | Total body mass | 0.3 | Full Range -4.8 to 4.1 | kilograms |
| Change in Total Mass and Regional Adipose Adiposiy | Single Arm | Total fat mass | -1.4 | Full Range -7.4 to 2.0 | kilograms |
| Change in Total Mass and Regional Adipose Adiposiy | Single Arm | Trunk fat mass | -0.9 | Full Range -4.6 to 0.2 | kilograms |
| Change in Total Mass and Regional Adipose Adiposiy | Single Arm | Extremity fat mass | -0.7 | Full Range -3.0 to 2.3 | kilograms |
| Change in Hepatic Lipid | Single Arm | -36 | Full Range -84 to 127 | ratio | |
| Intramyocellular Lipid (IMCL) | Single Arm | -30 | Full Range -85 to 43 | ratio | |
| Change in Percentage of Total Body Fat | Single Arm | -1.6 | Full Range -6.5 to 0.1 | percentage of total body fat | |
| Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO]) | Single Arm | Whole body insulin sensitiity | 1.05 | Full Range -2.44 to 3.73 | dL/min per μU/mL |
| Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO]) | Single Arm | hepaic glucose output (HGO) | -0.16 | Full Range -2.58 to 7.49 | dL/min per μU/mL |
| Change in Total and Regional Carbohydrate Metabolism During a 2-hr Hyperinsulinemic Euglycemic Clamp and [6,6-2H2] Glucose Studies (Peripheral Glucose Disposal [Rd],Hepatic Glucose Output [HGO]) | Single Arm | peripheral glucose disposal (Rd) | 1.16 | Full Range -3.08 to 3.85 | dL/min per μU/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm | 22 | |
| Overall Study | COMPLETED | Single Arm | 20 | |
| Overall Study | NOT COMPLETED | Single Arm | 2 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin irritation | Skin and subcutaneous tissue disorders | Open Label Testosterone Treatment | 1 | 20 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label Testosterone Treatment | 0 | 20 |
| Total, other adverse events | Open Label Testosterone Treatment | 1 | 20 |
| Total, serious adverse events | Open Label Testosterone Treatment | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25392748 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00365794
GET https://conductscience.org/api/trials/v1/NCT00365794/registered