Testosterone and glycaemic control in hypogonadal men. Version 1

• Research type

  Research Study

• Full title

  “Effects of testosterone on glycaemic control and other Cardiovascular Risk factors in Hypogonadal Men with uncontrolled Type 2 Diabetes: A randomized double – blinded placebo controlled add on trial using depot testosterone undecanoate”

• IRAS ID

  92912

• Contact name

  Hugh Jones

• Eudract number

  2011-006114-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Testosterone (male hormone) treatment is usually given to men with low levels of testosterone to help with symptoms such as tiredness, weakness, moodiness, depression and loss of libido (sex drive). It also helps to maintain the strength of bones and reduce the risk of broken bones. The purpose of this study is to find out the effect of adding testosterone to the standard diabetes treatment on glucose control, cardiovascular diseases (heart disease) obesity, lipid levels (cholesterol and other fats),body composition (distribution and measure of fat content in the body),intima media thickness in the carotid artery (thickness of the blood vessel in the neck which is a marker of heart disease)and on the liver function tests. This is a randomised , double blinded, placebo-controlled trial ?? meaning that patients will be randomly assigned (like the toss of a coin) to testosterone treatment or a placebo (dummy drug) and neither the patient nor the study doctor will know which one is given. If you participate in this study you will be assigned to one of the two treatment groups: Treatment arm 1: Testosterone standard treatment Treatment arm 2: Placebo (look-alike with no active ingredients) standard treatment. Testosterone ( nebido) has been approved by the regulatory agencies throughout the world including the United States Food and Drug Administration (FDA) and the European Committee for Human Medicinal Products (CHMP) and is available by prescription to treat individuals with hypogonadism ( low male hormone).

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0088

• Date of REC Opinion

  30 Mar 2012

• REC opinion

  Further Information Favourable Opinion