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NCT Number: NCT00365794

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

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.

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Key information

Conditions

Aging Body Weight Endocrine System Diseases Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

LAC-USC Medical Center GCRC

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical testosterone gel 10 g/day

Drug

Testosterone gel therapy for 20 weeks

Other names: Androgel

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. Change in Percentage of Total Body Fat

    Time frame: Baseline and 20 weeks

    Percentage of total body fat is quantified by DEXA scanning

  2. 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.

  3. 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.

  4. Plasma Lipids

    Time frame: Baseline to week 20

  5. Change in HOMA-IR

    Time frame: Baseline to week 20

    HOMA-IR is a measure of insulin resistance

  6. Change in Basal FFAs in Plasma

    Time frame: Baseline to week 20

    FFA (plasma free fatty acids) are measure of lipid metabolism

  7. Change in Plasma Free Fatty Acids During Glucose Clamp

    Time frame: Baseline to 20 weeks

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Solvay Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Aug 17, 2006
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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