AgingPhase 2NCT00365794
Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
A Phase 2 study testing Topical testosterone gel 10 g/day in people with Aging and Obesity, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging, Obesity, Insulin Resistance
- What is being tested?
- Topical testosterone gel 10 g/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Entry Criteria:
- Men > 60 years of age
- Total testosterone < 300 ng/dL
- Waist circumference >102 cm
- Fasting insulin level > 18 U/L
Who cannot join
- PSA > 4.1, symptoms of obstructive uropathy (AUA score > 14), unexplained prostate nodule or gland firmness
- Hematocrit > 50%
- Malignancy other than cutaneous cancers
- Sleep apnea requiring CPAP
- History of myocardial infarction, angina or stroke within the previous 6 months
- Clinical diagnosis of diabetes or FPG > 126 mg/dL
Show all 14Show fewer
- Hypothyroidism not controlled to euthyroid levels with medication for at least 3 months
- LDL-C >160 mg/dL
- Transaminases > 1.5X ULN
- Systemic anticoagulation with warfarin
- Active progressive resistance training
- Dieting for weight loss
- Active inflammatory condition (e.g. rheumatoid arthritis)
- Use of any anabolic agent (e.g. growth hormone, testosterone precursor, anabolic steroid)or cytokine therapy in the proceeding 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC-USC Medical Center GCRC
Los Angeles, California, 90033
About this study
Official title: Investigator Initiated Study of the Effects of Androgen Therapy on Carbohydrate and Lipid Metabolism In Elderly Men
- 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.
- Supplemental testosterone will decrease abdominal adipose tissue and hepatic fat) and appendicular fat and intramyocellular lipid in peripheral muscles (IMCL).
- Supplemental testosterone will improve insulin sensitivity by:
- Decreasing hepatic glucose output (HGO), a measure of central insulin resistance
- increasing peipheral glucose disposal (Rd), a measure of periperal insuln sensiivity
- . Improving peripheral glucose disposal (Rd) by reducing IMCL
- Increasing appendicular skeletal muscle mass
- OBJECTIVES:
- 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).
- 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.
Read the detailed description
Study Design: This is an investigator-initiated open label, study to investigate the effects of supplemental testosterone (gel formulation) to increase testosterone levels to the upper normal range in 12 older hypogonadal (testosterone levels less than 300 ng/dL) men with abdominal obesity and elevated fasting insulin levels. Subjects will be assigned to receive 10 g of transdermal testosterone (Androgel) every morning to achieve levels in the upper normal physiologic range (similar to men in the 3rd and 4th decades) for 20 weeks.
- For the primary objective, regional adipose tissue, namely DEXA measures of abdominal and appendicular fat mass and hepatic fat, and IMCL will be quantified by 1H-spectroscopy at baseline (study week 0) and at study week 20 (completion of study therapy).
- For the secondary objective, insulin sensitivity (peripheral Rd, hepatic glucose output [HGO]) and hepatic gluconeogenesis will be measured directly during a two stage hyperinsulinemic euglycemic clamp at baseline and study week 20.
- Indirect markers of lipid (adiponectin, ApoB 100) and carbohydrate metabolism (Fasting blood sugar, HOMA-IR) at study week 10, and study week 20.
All components of the study will be conducted in the USC NIH-funded (NCRR), General Clinical Research Center.
- Conditions
- Aging, Obesity, Insulin Resistance, Hypogonadism
- Being tested
- Topical testosterone gel 10 g/day
- Keywords
- Aging, Older men, Abdominal obesity, Central obesity, Insulin resistance, Low testosterone
- Medical subject headings
- Obesity, Insulin Resistance, Hypogonadism, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical testosterone gel 10 g/dayDrug
Also called Androgel
Testosterone gel therapy for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Open label treatment without masking with each participant serving as his own control. Measurements are compared before and after treatment. Receives: Drug: Topical testosterone gel 10 g/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Mass and Regional Adipose Adiposiy
Change in total body mass, total fat mass, trunk fat, and extremity fat
Measured: Baseline to 20 weeks
Change in Hepatic Lipid
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.
Measured: Baseline to week 20
Intramyocellular Lipid (IMCL)
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
Measured: Baseline to week 20
Secondary outcomes (7)
Change in Percentage of Total Body Fat
Percentage of total body fat is quantified by DEXA scanning
Measured: Baseline and 20 weeks
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])
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.
Measured: Baseline and 20 weeks
Change in Skeletal Muscle Mass by DEXA
Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle.
Measured: Baselne to 20 weeks
Plasma Lipids
Measured: Baseline to week 20
Change in HOMA-IR
HOMA-IR is a measure of insulin resistance
Measured: Baseline to week 20
Change in Basal FFAs in Plasma
FFA (plasma free fatty acids) are measure of lipid metabolism
Measured: Baseline to week 20
Change in Plasma Free Fatty Acids During Glucose Clamp
Measured: Baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Responsible party
- Principal investigator, Fred Sattler, MD, University of Southern California
- Investigators
- Fred R Sattler, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365794
- Sponsor's protocol ID
- GCRC Protocol 1156
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2006
- Last updated
- 26 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sattler F, He J, Chukwuneke J, Kim H, Stewart Y, Colletti P, Yarasheski K, Buchanan T. Testosterone Supplementation Improves Carbohydrate and Lipid Metabolism in Some Older Men with Abdominal Obesity. J Gerontol Geriatr Res. 2014 Jun 7;3(3):1000159. doi: 10.4172/2167-7182.1000159.
PubMed 25392748
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Study of the Effects of Androgen Therapy on Carbohydrate and Lipid Metabolism In Elderly Men
- ClinicalTrials.gov ID
- NCT00365794
- Acronym / sponsor ID
- GCRC Protocol 1156
- Conditions
- Aging, Obesity, Insulin Resistance, Hypogonadism
- Keywords
- Aging, Older men, Abdominal obesity, Central obesity, Insulin resistance, Low testosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Aug 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Posted 26 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Supplemental testosterone will decrease abdominal adipose tissue and hepatic fat) and appendicular fat and intramyocellular lipid in peripheral muscles (IMCL).
- Supplemental testosterone will improve insulin sensitivity by:
- Decreasing hepatic glucose output (HGO), a measure of central insulin resistance
- increasing peipheral glucose disposal (Rd), a measure of periperal insuln sensiivity
- . Improving peripheral glucose disposal (Rd) by reducing IMCL
- Increasing appendicular skeletal muscle mass
- OBJECTIVES:
- 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).
- 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.
Detailed description
Study Design: This is an investigator-initiated open label, study to investigate the effects of supplemental testosterone (gel formulation) to increase testosterone levels to the upper normal range in 12 older hypogonadal (testosterone levels less than 300 ng/dL) men with abdominal obesity and elevated fasting insulin levels. Subjects will be assigned to receive 10 g of transdermal testosterone (Androgel) every morning to achieve levels in the upper normal physiologic range (similar to men in the 3rd and 4th decades) for 20 weeks.
- For the primary objective, regional adipose tissue, namely DEXA measures of abdominal and appendicular fat mass and hepatic fat, and IMCL will be quantified by 1H-spectroscopy at baseline (study week 0) and at study week 20 (completion of study therapy).
- For the secondary objective, insulin sensitivity (peripheral Rd, hepatic glucose output [HGO]) and hepatic gluconeogenesis will be measured directly during a two stage hyperinsulinemic euglycemic clamp at baseline and study week 20.
- Indirect markers of lipid (adiponectin, ApoB 100) and carbohydrate metabolism (Fasting blood sugar, HOMA-IR) at study week 10, and study week 20.
All components of the study will be conducted in the USC NIH-funded (NCRR), General Clinical Research Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Topical testosterone gel 10 g/dayOpen label treatment without masking with each participant serving as his own control. Measurements are compared before and after treatment. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Entry Criteria:
- Men > 60 years of age
- Total testosterone < 300 ng/dL
- Waist circumference >102 cm
- Fasting insulin level > 18 U/L
Key exclusion criteria (14 listed)
- PSA > 4.1, symptoms of obstructive uropathy (AUA score > 14), unexplained prostate nodule or gland firmness
- Hematocrit > 50%
- Malignancy other than cutaneous cancers
- Sleep apnea requiring CPAP
- History of myocardial infarction, angina or stroke within the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical testosterone gel 10 g/dayAlso: AndrogelTestosterone gel therapy for 20 weeks | Drug | Single arm |
Primary outcome
Change in Total Mass and Regional Adipose Adiposiy
Time frame: Baseline to 20 weeks
Change in total body mass, total fat mass, trunk fat, and extremity fat
Change in Hepatic Lipid
Time frame: 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.
Intramyocellular Lipid (IMCL)
Time frame: 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
7 secondary outcomes
Change in Percentage of Total Body Fat
Time frame: Baseline and 20 weeks
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])
Time frame: Baseline and 20 weeks
Change in Skeletal Muscle Mass by DEXA
Time frame: Baselne to 20 weeks
Plasma Lipids
Time frame: Baseline to week 20
Change in HOMA-IR
Time frame: Baseline to week 20
Change in Basal FFAs in Plasma
Time frame: Baseline to week 20
Change in Plasma Free Fatty Acids During Glucose Clamp
Time frame: Baseline to 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25392748Sattler F, He J, Chukwuneke J, Kim H, Stewart Y, Colletti P, Yarasheski K, Buchanan T. Testosterone Supplementation Improves Carbohydrate and Lipid Metabolism in Some Older Men with Abdominal Obesity. J Gerontol Geriatr Res. 2014 Jun 7;3(3):1000159. doi: 10.4172/2167-7182.1000159.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred R Sattler, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical testosterone gel 10 g/day in people with Aging and Obesity, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Mass and Regional Adipose Adiposiy (time frame: Baseline to 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00365794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.