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Phase 4 Completed N=137 Randomized Double-blind Treatment

Testosterone Replacement in Men With Diabetes and Obesity

Source: ClinicalTrials.gov NCT01127659 ↗
Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Insulin Sensitivity — 6.66; 5.12; 11.37; 12.93 mg/kg fat free mass/min
◆ Published Evidence
Highly cited
279citations · ~28 / year
Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes.
Diabetes care · 2016 · Open access · Likely link

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.

Linked Publications (3)

  • Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes.
    Diabetes care · 2016 · 279 citations · Open access · Likely link
  • Effect of Testosterone on FGF2, MRF4, and Myostatin in Hypogonadotropic Hypogonadism: Relevance to Muscle Growth.
    The Journal of clinical endocrinology and metabolism · 2019 · 46 citations · Open access · Likely link
  • Testosterone Increases the Expression and Phosphorylation of AMP Kinase α in Men With Hypogonadism and Type 2 Diabetes.
    The Journal of clinical endocrinology and metabolism · 2020 · 35 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01127659) and the linked publication. 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. Informational only — not medical advice.

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