Metabolic Effects of Testosterone Replacement Therapy in Patients with Type 2 Diabetes Mellitus or Metabolic Syndrome: A Meta-Analysis

Table 1

Characteristics of the randomized clinical studies included in the meta-analysis.

Study, year	Objects	Group	Treatment	Samples	Age	Duration of treatment	BMI	HbA1c
Shigehara, 2017	MetS + free testosterone (FT) ≤11.8 pg/ml	TRT	Testosterone enanthate 250 mg IM every 4 weeks	32	67.0 ± 9.4	12 m	NA	6.5 ± 0.9
		Control	No treatment	33	69.3 ± 9.7		NA	6.3 ± 1.1
Groti, 2018	T2DM + total testosterone (TT) <11 nmol/l and/or free testosterone (FT) level <220 pmol/l	TRT	Testosterone undecanoate (TU) 1000 mg IM every 10 weeks	28	60.2 ± 7.2	12 m	34.0 ± 4.4	8.1 ± 1.0
		Control	Placebo	27			32.6 ± 3.7	7.2 ± 0.8
Khripun, 2018	T2DM + TT <12.1 nmol/L	TRT	1%-transdermal T-gel 50 mg qd + dietary control	40	53.3 ± 5.4	9 m	34.0 ± 1.9	7.8 ± 1.8
		Control	Dietary control	40	54.1 ± 5.6		33.6 ± 2.2	6.7 ± 1.4
Di, 2017	T2DM + TT <12 nmol/L	TRT	TU capsule 80 mg po bid, two weeks later 40 mg bid + hypoglycemic agents	42	44.5 ± 5.7	6 m	26.7 ± 2.4	7.7 ± 2.0
		Control	Hypoglycemic agents	40	45.5 ± 5.2		24.6 ± 2.5	7.6 ± 1.3
Dhindsa, 2017	T2DM + FT <6.5 ng/dL	TRT	TU 250 mg IM every 2 weeks	20	54.6	6 m	39.8 ± 7.8	7.0 ± 1.1
		Control	Placebo	14
Hackett, 2014	T2DM + FT <225 pmmol/L	TRT	TU 1000 mg IM in the 0th, 6th, and 18th weeks	91	61.2 ± 10.5	7.5 m	33.0 ± 6.1	7.7 ± 1.3
		Control	Placebo	95	62.0 ± 9.3		32.4 ± 5.5	7.5 ± 1.2
Gianatti, 2014	T2DM + TT <12 nmmol/L	TRT	TU 1000 mg IM in the 0th, 6th, and 18th weeks	45	62.0 ± 7.4	10 m	31.5 ± 5.3	6.8 ± 0.9
		Control	Placebo	43			33.4 ± 3.0	7.1 ± 0.6
Jones, 2011	T2D + TT < 11 nmmol/L	TRT	Transdermal testosterone gel 60 mg daily + hypoglycemic agents	108	59.9 ± 9.1	6 m	32.9 ± 6.6	NA
		Control	Placebo + hypoglycemic agents	112	59.9 ± 9.4		31.3 ± 5.4	NA
Aversa, 2010	MetS + TT <3.0 ng/mL	TRT	TU 1000 mg IM every 12 weeks	40	51.6 (49.8–53.4)	12 m	31.0 ± 6.2	6.6 ± 1.3
		Control	Placebo	10	52.8 (50.5–55.0)	12 m	30.2 ± 4.5	5.7 ± 0.5
Kalinchenko, 2010	MetS + TT <12.0 nmol	TRT	TU 1000 mg IM 0th, 6th, and 18th weeks	113	51.6 (49.8–53.4)	7.5 m	35.3 ± 1.8	NA
		Control	Placebo	71	52.8 (50.5–55.0)		34.2 ± 2.1	NA
Kapoor, 2006	T2DM + TT <11.8 nmol/l	TRT	TU 200 mg IM 2 weeks + hypoglycemic agents	12	64.0 ± 1.3	3 m	33.0 ± 0.9	7.3 ± 0.2
		Control	Placebo + hypoglycemic agents	12
Boyanov, 2003	T2DM + TT <15.1 nmol/l	TRT	TU 120 mg po QD + hypoglycemic agents	24	57.5 ± 4.8	3 m	31.1 ± 4.8	10.4 ± 1.6
		Control	Hypoglycemic agents	24			31.0 ± 4.9	10.3 ± 1.6
Gopal, 2010	T2D + FT <64.8 pg/mL	TRT	TU 200 mg IM every 15 days + conventional treatment	11	44.2 ± 3.3	3 m	23.9 ± 4.5	7.0 ± 2.5
		Control	Placebo + conventional treatment	11
Francomano, 2014	MetS + TT < 320 ng/dL (11 nmol/L)	TRT	TU 1000 mg IM every 12 weeks	20	58.0 ± 10.0	60 m	31.0 ± 5.0	NA
		Control	No treatment	20	57.0 ± 8.0		31.0 ± 6.0	NA
Yang, 2014	MetS + hypogonadism	TRT	TU 40 mg po bid	60	56.2 ± 5.5	12 m	NA	NA
		Control	No treatment	20			NA	NA
Zhao, 2016	T2D + T <12 mol/L	TRT	TU 20 mg po tid + conventional treatment	35	50.7 ± 5.6	6 m	29.0 ± 4.1	7.2 ± 1.7
		Control	Conventional treatment	30	52.5 ± 3.2		30.3 ± 3.8	7.7 ± 1.2
Wu, 2015	T2D + T <12 mol/L	TRT	TU 250 mg IM QM + conventional treatment	30	45.0∼65.0	6 m	NA	8.7 ± 2.6
		Control	Placebo + conventional treatment	30			NA	8.9 ± 3.0
Heufelder, 2009	T2D + MetS + T <12 mol/L	TRT	Transdermal testosterone gel 50 mg daily + sports + hypoglycemic agents	16	57.3 ± 1.4	12 m	32.1 ± 0.5	7.5 ± 0.1
		Control	Sports + hypoglycemic agents	16	55.9 ± 1.5		32.5 ± 0.5	7.5 ± 0.1

TT, total testosterone; FT, free testosterone; T2D, type 2 diabetes mellitus; TRT: testosterone replacement therapy.