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Trial record 5 of 361 for:    Recruiting, Not yet recruiting, Available Studies | "weight loss"

Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)

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ClinicalTrials.gov Identifier: NCT02959853
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Rui Chen, Baylor College of Medicine

Brief Summary:
After the age of 40, there is a gradual decline in the production of testosterone. Among obese men, the decline in testosterone levels is exacerbated by the suppression of the hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in turn exert a negative feedback on the hypothalamus and pituitary, leading to the inhibition of production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH), and as a consequence, of testosterone by the testis resulting in hypogonadotropic hypogonadism (HH). Though bone loss is a well recognized side effect of AI in certain populations, such as women with breast cancer, HH obese men present high levels of circulating estrogens that could potentially prevent them from bone loss, estradiol being the main regulator of the male skeleton. This study is designed to determine if aromatase inhibitors in combination with weight loss, compared to weight loss alone, will have a positive effect on muscle strength, symptoms of hypogonadism, and body composition without negatively impacting bone mineral density and bone quality. Results from this study will help determine if certain groups of obese patients would benefit from therapy with aromatase inhibitors.

Condition or disease Intervention/treatment Phase
Hypogonadism Severe Obesity Drug: Anastrazole Behavioral: weight loss Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)
Study Start Date : June 2016
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: weight loss
Patients given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Behavioral: weight loss
Experimental: aromatase inhibitor (anastrazole) plus weight loss
Patient placed on an aromatase inhibitor anastrazole 1 mg daily plus given counseling on diet and exercise in order to achieve a goal weight loss of 10 percent
Drug: Anastrazole
Other Name: Arimidex
Behavioral: weight loss



Primary Outcome Measures :
  1. muscle strength [ Time Frame: 6 months ]
    muscle strength in the form of knee extension strength as measured by biodex machine

  2. symptoms of hypogonadism [ Time Frame: 6 months ]
    symptoms of hypogonadism measured by total symptom score with Quantitative Androgen Deficiency in Aging Male (ADAM) questionnaire

  3. symptoms of hypogonadism [ Time Frame: 6 months ]
    symptoms of hypogonadism measured by total symptom score with International Index of Erectile Function (IIEF) questionnaire

  4. symptoms of hypogonadism [ Time Frame: 6 months ]
    symptoms of hypogonadism measured by total symptom score with Stanford physical activity 7 day recall questionnaire

  5. symptoms of hypogonadism [ Time Frame: 6 months ]
    symptoms of hypogonadism measured by total symptom score with Short Form 36 Healthy Survey (SF-36) questionnaire

  6. symptoms of hypogonadism [ Time Frame: 6 months ]
    symptoms of hypogonadism measured by total symptom score with Impact of Weight on Quality of Life Questionnaires Lite (IWQOL)


Secondary Outcome Measures :
  1. body composition [ Time Frame: 6 months ]
    body composition (body fat percentage) measured by Dual-energy X-ray absorptiometry (DXA) scan

  2. visceral adipose tissue [ Time Frame: 6 months ]
    visceral adipose tissue ratio measured by DXA scan

  3. bone mineral density [ Time Frame: 6 months ]
    bone mineral density as measured by DXA scan

  4. bone quality [ Time Frame: 6 months ]
    bone quality as measured by high resolution peripheral quantitative computed tomography scan



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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severely obese (BMI >= 35) male veterans with hypogonadotropic hypogonadism defined as low total testosterone (lower than 300 ng/dl) between 35-65 years of age
  • Luteinizing hormone (LH) lower than 9 U/L
  • estradiol above 40 pmol/l
  • normal Free T4 (FT4), Thyroid Stimulating Hormone (TSH), prolactin, cortisol, Adrenocorticotropic hormone (ACTH), and Insulin-like growth factor-1 (IGF-1) levels.
  • Subjects must be ambulatory, willing and able to provide written informed consent

Exclusion Criteria:

  • clinical or biochemical evidence of pituitary or hypothalamic disease
  • any ongoing illness that, in the opinion of the investigator, could prevent the subject from completing study
  • any med known to affect gonadal hormones, steroid hormone-binding globulin or bone metabolism, e.g.,

    • androgens
    • estrogens
    • glucocorticoids
    • phenytoin
    • bisphosphonates
    • any medication known to interfere with anastrozole metabolism, e.g. tamoxifen or estrogens
  • diseases known to interfere with bone metabolism as

    • osteoporosis
    • hyperparathyroidism
    • untreated hyperthyroidism
    • osteomalacia
    • chronic liver disease
    • renal failure
    • hypercortisolism
    • malabsorption
    • immobilization
    • patients with a Total T score lower than -2.0 at Lumbar Spine or Left Femur.
  • patients with symptomatic prostate disease, prostate carcinoma, or elevated serum Prostate-specific antigen (PSA) >4 ng/ml or >3 for subjects with a family history of prostate cancer among 1st degree relatives needs urologic evaluation before admission into study
  • hematocrit greater than 50%
  • untreated severe obstructive sleep apnea
  • severe lower urinary tract symptoms with International Prostate Symptom Score (IPSS) above 19
  • documented heart failure
  • cardiovascular disease
  • liver disease
  • excessive alcohol or substance abuse
  • unstable weight (changes in weight more than ± 2 kg) during the last 3 months
  • history of bariatric surgery
  • subjects with elevated liver enzymes as alanine transaminase (ALT), aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and bilirubin at greater than twice the upper limit of normal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959853


Contacts
Contact: Reina Villareal, MD (713) 791-1414 ext 27534 Reina.Villareal@bcm.edu

Locations
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Reina Villareal, MD    713-791-1414 ext 27534    Reina.Villareal@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Reina Villareal, MD Baylor College of Medicine

Responsible Party: Rui Chen, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02959853     History of Changes
Other Study ID Numbers: H-36912
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: November 2016

Keywords provided by Rui Chen, Baylor College of Medicine:
Hypogonadism
Severe obesity

Additional relevant MeSH terms:
Weight Loss
Hypogonadism
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Gonadal Disorders
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Aromatase Inhibitors
Anastrozole
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents