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Trial record 16 of 213 for:    "Hypogonadism" | "Androgens"

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

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ClinicalTrials.gov Identifier: NCT00365794
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Fred Sattler, MD, University of Southern California

Tracking Information
First Submitted Date  ICMJE August 16, 2006
First Posted Date  ICMJE August 17, 2006
Results First Submitted Date  ICMJE March 22, 2017
Results First Posted Date  ICMJE August 26, 2019
Last Update Posted Date August 26, 2019
Study Start Date  ICMJE August 2006
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2006)
  • Regional adipose tissue (visceral and subcutaneous abdominal [VAT, SAT] by MRI, Hepatic fat mass by 1H-MRI spectroscopy
  • IMCL [intramyocellular lipid] by 1H-MRI spectroscopy)
  • Total appendicular and intermuscular fat by Tomovision analysis of MRI images
Change History Complete list of historical versions of study NCT00365794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Change in Percentage of Total Body Fat [ Time Frame: Baseline and 20 weeks ]
    Percentage of total body fat is quantified by DEXA scanning
  • 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 ]
    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.
  • Change in Skeletal Muscle Mass by DEXA [ Time Frame: Baselne to 20 weeks ]
    Skeletal muscle mass was assesed by regional DEXA to quantify appendicular lean tissues which is primarily muscle.
  • Plasma Lipids [ Time Frame: Baseline to week 20 ]
  • Change in HOMA-IR [ Time Frame: Baseline to week 20 ]
    HOMA-IR is a measure of insulin resistance
  • Change in Basal FFAs in Plasma [ Time Frame: Baseline to week 20 ]
    FFA (plasma free fatty acids) are measure of lipid metabolism
  • Change in Plasma Free Fatty Acids During Glucose Clamp [ Time Frame: Baseline to 20 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2006)
  • 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])
  • Hepatic glucose synthesis from glycogen, glycerol and the Krebs tricarboxylic acid (TCA) cycle using glucose, D2O, and [U-13C3] palmitate isotope dilution
  • Skeletal muscle mass by DEXA and MRI
  • Exploratory measures (adiponectin and Apolipoprotein B levels)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
Official Title  ICMJE Investigator Initiated Study of the Effects of Androgen Therapy on Carbohydrate and Lipid Metabolism In Elderly Men
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
No masking. This was an open label (un-blinded)
Primary Purpose: Treatment
Condition  ICMJE
  • Aging
  • Obesity
  • Insulin Resistance
  • Hypogonadism
Intervention  ICMJE Drug: Topical testosterone gel 10 g/day
Testosterone gel therapy for 20 weeks
Other Name: Androgel
Study Arms  ICMJE Experimental: Single arm
Open label treatment without masking with each participant serving as his own control. Measurements are compared before and after treatment.
Intervention: Drug: Topical testosterone gel 10 g/day
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2019)
22
Original Enrollment  ICMJE
 (submitted: August 16, 2006)
12
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Entry Criteria:
  • Men > 60 years of age
  • Total testosterone < 300 ng/dL
  • Waist circumference >102 cm
  • Fasting insulin level > 18 U/L

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00365794
Other Study ID Numbers  ICMJE GCRC Protocol 1156
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fred Sattler, MD, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Fred R Sattler, MD University of Southern California
PRS Account University of Southern California
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP