Testosterone Replacement in Men With Diabetes and Obesity

NCT01127659 | Completed Phase 4 Results

• 2 other identifiers: NIH testosterone grantR01DK075877
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogonadism

Keywords

diabetes; hypogonadism; obesity; testosterone; insulin sensitivity; inflammation

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  measured by HE clamps (baseline and 6 mths)

  baseline to 6 months

Secondary Outcomes (1)

• Body Composition

  baseline to 6 months

Study Arms (6)

diabetes with HH-active

ACTIVE COMPARATOR

Subjects with diabetes and hypogonadotropic hypogonadism. They will be randomized to testosterone intervention.

Drug: testosterone

diabetes with normal testosterone

NO INTERVENTION

Eugonadal subjects with diabetes. They will not be treated

obese with HH-active

ACTIVE COMPARATOR

Obese non-diabetic men hypogonadotropic hypogonadism. They will be randomized to testosterone intervention.

Drug: testosterone

obese with normal testosterone

NO INTERVENTION

Eugonadal non-diabetic obese subjects. They will not be treated

Diabetes with HH-placebo

PLACEBO COMPARATOR

Subjects with diabetes and hypogonadotropic hypogonadism. They will be randomized to placebo.

Drug: placebo

Obese with HH-placebo

PLACEBO COMPARATOR

Obese non-diabetic men hypogonadotropic hypogonadism. They will be randomized to placebo.

Drug: placebo

Interventions

testosterone DRUG

intramuscular every 2 weeks

diabetes with HH-active; obese with HH-active

placebo DRUG

saline intramuscular every 2 weeks

Diabetes with HH-placebo; Obese with HH-placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• )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\<30); 7)HIV or Hepatitis C positive status; 9)Participation in any other concurrent clinical trial; 10)Any other life-threatening, non-cardiac disease; 11)Use of over the counter health supplements which contain androgens; 12)Use of an investigational agent or therapeutic regimen within 30 days of study; 13)prostate nodule or severe enlargement on digital rectal examination; 14)Use of testosterone currently or in the past 4 months; 15)Hematocrit \> 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.

Sponsors & Collaborators

• University at Buffalo: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

115 Flint Road

Williamsville, New York, 14221, United States

Location

Related Publications (3)

• Ghanim H, Dhindsa S, Batra M, Green K, Abuaysheh S, Kuhadiya ND, Makdissi A, Chaudhuri A, Sandhu S, Dandona P. Testosterone Increases the Expression and Phosphorylation of AMP Kinase alpha in Men With Hypogonadism and Type 2 Diabetes. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1169-75. doi: 10.1210/clinem/dgz288.

  PMID: 31858126 DERIVED

• Ghanim H, Dhindsa S, Batra M, Green K, Abuaysheh S, Kuhadiya ND, Makdissi A, Chaudhuri A, Dandona P. Effect of Testosterone on FGF2, MRF4, and Myostatin in Hypogonadotropic Hypogonadism: Relevance to Muscle Growth. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2094-2102. doi: 10.1210/jc.2018-01832.

  PMID: 30629183 DERIVED

• Dhindsa S, Ghanim H, Batra M, Kuhadiya ND, Abuaysheh S, Sandhu S, Green K, Makdissi A, Hejna J, Chaudhuri A, Punyanitya M, Dandona P. Insulin Resistance and Inflammation in Hypogonadotropic Hypogonadism and Their Reduction After Testosterone Replacement in Men With Type 2 Diabetes. Diabetes Care. 2016 Jan;39(1):82-91. doi: 10.2337/dc15-1518. Epub 2015 Nov 29.

  PMID: 26622051 DERIVED

MeSH Terms

Conditions

Hypogonadism; Diabetes Mellitus; Obesity; Insulin Resistance; Inflammation

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Pathologic Processes

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Paresh Dandona
• Organization: University of Buffalo

pdandona@kaleidahealth.org

716) 961-9900

Study Officials

• Paresh Dandona, MBBS

  SUNY at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 29, 2022
• Results First Posted: March 7, 2017

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)