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Clinical Trial Details

NCT ID: NCT00365794
Date Last Changed: July 20, 2011

Overview

Research Study Summary

A Phase 2 clinical study for patients with Aging, Obesity, Insulin Resistance or Hypogonadism

Purpose

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 fat (visceral adominal adipose tissues (VAT), subcutaneous abdominal adipose tissue (SAT), and hepatic fat) and intramyocellular lipid in peripheral muscles(IMCL).

  2. Supplemental testosterone will improve insulin sensitivity by:

  3. Decreasing hepatic glucose output (HGO), a measure of central insulin resistance

  4. Decreasing VAT

  5. Decreasing SAT

  6. Increasing adiponectin production

  7. Improving peripheral glucose disposal (Rd) by reducing IMCL

  8. Increasing appendicular skeletal muscle mass and basal metabolic rate

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 VAT, SAT, and hepatic fat) and peripheral skeletal muscle fat (IMCL and intermyocellular fat).

  2. Secondary Objectives: To determine the effects of supplemental testosterone to achieve testosterone levels in the upper normal physiologic range:

  3. on hepatic glucose output (HGO) and peripheral glucose disposal (Rd)

  4. on hepatic glucose synthesis from glycogen, glycerol and the Krebs cycle using [1,6-13C2C] glucose, D2O, and [U-13C3] palmitate isotope dilution studies

  5. on adiponectin and apoprotein B levels

  6. on basal metabolic rate (REE, R/Q) as related to changes in skeletal muscle mass

Results of this study will provide greater understanding whether androgen therapy enhances insulin sensitivity by decreasing HGO, decreasing adiponectin production, improving peripheral Rd and if these desired effects are achieved, whether they are due to reductions in VAT, SAT, liver fat, 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.

To Learn more

Recruitment Details

Phase
2
Gender
Male
Age
60 to 90 Years
Overall Status
Recruiting
Lead Sponsor
University of Southern California
Duration
59 Months
Facility Type
N/A
Compensation

Eligibility

Male ages 60 Years to 90 Years

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

Site Locations (1)

Country State City Zip Facility and Contact
United States California Los Angeles 90033 LAC-USC Medical Center GCRC

Contact

Yolanda Stewart
323-226-7571 ext. 7571
E-mail:

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