STRIDE - 2 follow up study
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’’ Observational follow up study (STRIDE 2 STUDY)
IRAS ID
191140
Contact name
Hugh Jones
Contact email
Duration of Study in the UK
8 years, 0 months, 1 days
Research summary
The primary objective of this observational extension (as part of normal clinical routine practice to the STRIDe study) is to determine if any benefits observed as a result of testosterone replacement therapy (using intramuscular testosterone undeconoate - Nebido®) persist or continue to improve in the longer-term. This is important to establish in this cohort of men with poorly controlled diabetes at baseline. Nebido has been used since 2005 in the UK and is routinely used as one of the formulations of testosterone to replace testosterone to levels within the normal healthy range in male hypogonadism. These patients will be seen in follow-up clinics and monitored as per international clinical guidelines. In addition body composition, carotid intimal media thickness (as a surrogate marker of atherosclerosis), 24 hour ambulatory blood pressure and questionnaires will be performed as laid out in the protocol. We plan to follow up the patients for 5 years after their initial dose of Nebido given during the STRIDe study.
With availability of further funds we would like to conduct a follow up study to STRIDE study where those patients who completed STRIDE trial are followed up for a further 5 year period after they have gone on to active treatment (STRIDE – 2). This follow up does not include them being on the IMP. They will be receiving treatment according to the current clinical practice and we would only like to collect the relevant data at regular intervals as specified below in this document over 5 years period. This would enable us to understand the effects of the IMP over longer period and to see if the beneficial effects are maintained over long term follow up.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0038
Date of REC Opinion
16 Feb 2016
REC opinion
Favourable Opinion