Cardiovascular Outcomes of Low Testosterone

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study plans to learn more about heart and vascular aging in men. In some men as they get older, testosterone levels fall below the normal range for young men. Also, as men get older cardiovascular health worsens. This can lead to high blood pressure and heart disease. In this study we want to find out what causes cardiovascular health to worsen in older men. Also we want to find out what happens when testosterone levels are lowered for a short time. Specifically, we want to see if the reduction in cardiovascular health in older men with low testosterone levels is because of damage to mitochondria. Mitochondria are the main power supply of the cells in our body. The results from this study will help to understand why cardiovascular health declines in older men with low testosterone levels compared to younger men and older men who have higher testosterone levels. Knowing this information will help to develop therapies to prevent heart disease in men.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Acyline; Anastrozole; Aromatase Inhibitors; Hormone Antagonists; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

1. Men aged 18-40 years and 50-75 years

2. Chronically low testosterone group will have testosterone concentrations <300 ng/dl, and young and older normal testosterone groups will have testosterone levels 400-1000 ng/dl

3. No use of sex hormones for at least 1 year

4. Body mass index <40 kg/m2

5. Nonsmokers

6. Resting blood pressure <160/90 mmHg

7. Fasting plasma glucose <126 mg/dL

8. Healthy, as determined by medical history, physical examination, standard blood chemistries (chemistry panel, complete blood clot and circulating thyroid levels) and a graded exercise stress test with monitoring of blood pressure and electrocardiogram (ECG)

9. Sedentary or recreationally active (< 3 days/wk of vigorous aerobic exercise)

10. No use of medications that might influence cardiovascular function including anti-hypertensive, lipid lowering medications, and corticosteroids

11. No use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior and throughout the study.

Exclusion Criteria:

1. Contraindications to:

1. Gonadotropin releasing hormone (GnRH) antagonist

2. Testosterone gel and aromatase inhibitor including hypersensitivity to Acyline, Androgel®, Arimidex®

3. Extrinsic peptide hormones, mannitol, GnRH or any other GnRH analogs

2. History of or active prostate or breast cancer or other sex hormone-dependent neoplasms

3. Pre-existing or active cardiac, renal or hepatic disease

4. History of stomach ulcer or bleeding

5. History of epilepsy or other seizure disorder

6. Diabetes

7. Active infection

8. Disease that affects the nervous system

9. Abnormal resting ECG

Additionally, men participating in the gonadal suppression intervention study will do so with the understanding that they will be randomly assigned to study groups that involve either GnRH antagonist plus testosterone gel plus placebo tablet (33% chance), GnRH antagonist plus testosterone gel plus aromatase inhibitor tablet (33% chance) or GnRH antagonist plus placebo gel plus placebo tablet (33% chance).