Phase 4 N=137 Randomized Double-blind Treatment

Testosterone Replacement in Men With Diabetes and Obesity

Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT01127659 ↗

Enrolled (actual)

137

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Insulin Sensitivity — 6.66; 5.12; 11.37; 12.93 mg/kg fat free mass/min

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: testosterone (Drug); placebo (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: Male
Sponsor: University at Buffalo
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin Sensitivity	6.66; 5.12; 11.37; 12.93; 10.29; 12.30	—
SECONDARY Body Composition	44.5; 44.5; 50.2; 48.8; 34.0; 40.2	—

Summary

The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy. This will be done by comparing the changes in several body response indicators following treatment with testosterone in diabetic or obese-non diabetic men with low testosterone levels and comparing them to diabetic or obese-non diabetic men with low testosterone who are not treated with testosterone.

Eligibility Criteria

Inclusion Criteria

T2D arm: Males with age 30-65 years
Obese non-diabetic arm: Obese non-diabetic males with age 30-65 years

Exclusion Criteria

1)Coronary event or procedure(myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous twelve weeks; 2) PSA > 4ng/ml; 3)Hemoglobin A1c > 8%; 4)h/o prostate carcinoma; 5)Hepatic disease (transaminase > 3 times normal) or cirrhosis; 6)Renal impairment (defined as GFR 50%; 16)History of untreated severe obstructive sleep apnea(defined as apnea-hypopnea index ≥30); 17)symptoms suggestive of severe BPH; 18)Congestive heart failure, class III or IV; 20)Known to have anemia secondary to iron, B12 or folic acid deficiency; 21)bone marrow disorder such as myelodysplasia or aplastic anemia; 22) currently suffering from symptomatic depression, with or without treatment; 23) history of severe depression in the past which needed hospitalization; 24)currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition; 25)planning to have children. 26) Subjects on testosterone or with testosterone replacement in the past 4 months will be excluded.

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Data sourced from ClinicalTrials.gov (NCT01127659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.