Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479609
Status:
UNKNOWN
Last Update Posted:
2008-05-07
First Post:
2007-05-25
Brief Title:
Testosterone Therapy in Men With Low Testosterone Levels and Metabolic Syndrome or Early Stages of Type 2 Diabetes
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Randomised Placebo Controlled Study of Transdermal Testosterone Therapy to Investigate the Efficacy and Safety in Men With Abdominal Obesity Low Testosterone Levels and Early Stages of the Metabolic Cluster Syndrome
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Men with metabolic syndrome often have lower than normal testosterone levels and low testosterone levels have been suggested to predispose for development of type2 diabetes The aim of the study is to evaluate if normalisation of serum testosterone levels in men with metabolic syndrome Abdominal obesity hypertension dyslipidemia insulin resistance and pre-diabetes or overt type diabetesimproves sensitivity to insulin and improves the signs of the metabolic syndrome
Detailed Description:
Background The metabolic syndrome constitutes a cluster of risk factors for cardiovascular disease with increased morbidity and mortality In essence the metabolic syndrome is referred to as a concomitant occurrence of hypertension hyperlipidemia impaired glucose tolerance with insulin resistance and abdominal obesity The presence of abdominal obesity seems to be a key factor in development of the metabolic derangements that occur and is a part of all different definitions that are currently used as diagnostic criterias for the metabolic syndrome A number of studies have verified a serious prognosis for males and females presenting with the abdominal obesity
The term metabolic syndrome alludes to a common mechanism behind the development of the different sings of this condition but so far the etiological interrelationship is not known In males with the metabolic syndrome low serum testosterone levels is a common finding and data from some longitudinal studies suggest that low testosterone levels precedes the development of abdominal obesity and seem to facilitate later development of hypertension hyperlipidemia and hyperglycemia A few smaller studies have tested the hypothesis that testosterone therapy may have a beneficial metabolic effect in males with the metabolic syndrome and implicated that low testosterone levels is a part of disease facilitating factors in these males
Current study The current study ARTinMMS is an interventional phase IV study in males 30-70 years inclusive with early stages of the metabolic syndrome defined as abdominal obesity glucose intolerance or overt type 2 diabetes defined according to the criterias suggested by the International Federation for Diabetes The study is a 24 weeks randomized placebo controlled parallel group multi-centre study where males with serum testosterone levels below 12 nmolL will be treated with testosteroneplacebo total duration of study including follow-up visit 26-27 weeks The primary endpoint of the study is assessment of insulin sensitivity by measurement of fasting plasma glucose and insulin levels and calculated according to the QUICKI formula In addition glucose tolerance will be tested with a standard oral glucose tolerance test as well as assessment of blood lipids and blood pressure
A total of 176 males will be recruited and randomized for the study after a screening procedure to verify eligibility for the study Males who can participate must fulfil a series of inclusion and exclusion criteria which in addition to the metabolic syndrome and low testosterone levels require HbA1c levels below 75 stable blood pressure control and cholesterol levels below 8 mmolL Medical treatment for these conditions are accepted but diabetes treatment is limited to metformin
Before entering into the study and during the study males will be followed with blood tests and glucose tolerance assessment and physical examination In all the study requires five clinical visits Base-line observations and randomization visit two visits during the treatment phase after 12 and 23 weeks of therapy and a follow-up visit after cessation of therapy
A few exploratory variables will be assess such as markers for changes in cholesterol metabolism adiponectin and all subjects in the study will be characterized with genotype analysis of CAG repeat polymorphism of the androgen receptor A subset of patients will be examined with CT of the abdomen to assess eventual changes in intra abdominal fat mass and liver attenuation
Safety procedures involve assessment of the prostate digital rectal examination and PSA levels and Hb levels at baseline and throughout the study
Study medication Males enrolled in the study will be treated with daily application of 75 g of a 1 testosterone hydroalcoholic gel 75 mg of testosterone applied on specified skin sites or a placebo gel
Time plan The study is planned to start in q2 2007 at 12 different centres in Austria Germany and Sweden Each centre is anticipated to recruit 10 -30 subjects during a 2 months period To facilitate recruitment newspaper advertising and web based eligibility screening will be used if feasible After an 1-3 weeks screening period eligible subjects are randomized to active or placebo therapy Two evaluations are made during the treatment phase the first after 12 and the second after 24 weeks Efficacy and safety assessments are performed at these visits Competitive enrolment is used after the first six weeks of the recruitment period enabling all centres to recruit an up-front agreed number of subjects
Data capturing and laboratory routines A centralized internet based system will be used for data capturing communication with the study staff and automatic entry of laboratory data All laboratory analysis will be performed at or through a core laboratory LFK in Kiel A paper CRF will be used for primary entry of patient data which are subsequently transcribed into an electronic CRF All study centres will be trained during the investigators meeting in management of the data capturing system
The term metabolic syndrome alludes to a common mechanism behind the development of the different sings of this condition but so far the etiological interrelationship is not known In males with the metabolic syndrome low serum testosterone levels is a common finding and data from some longitudinal studies suggest that low testosterone levels precedes the development of abdominal obesity and seem to facilitate later development of hypertension hyperlipidemia and hyperglycemia A few smaller studies have tested the hypothesis that testosterone therapy may have a beneficial metabolic effect in males with the metabolic syndrome and implicated that low testosterone levels is a part of disease facilitating factors in these males
Current study The current study ARTinMMS is an interventional phase IV study in males 30-70 years inclusive with early stages of the metabolic syndrome defined as abdominal obesity glucose intolerance or overt type 2 diabetes defined according to the criterias suggested by the International Federation for Diabetes The study is a 24 weeks randomized placebo controlled parallel group multi-centre study where males with serum testosterone levels below 12 nmolL will be treated with testosteroneplacebo total duration of study including follow-up visit 26-27 weeks The primary endpoint of the study is assessment of insulin sensitivity by measurement of fasting plasma glucose and insulin levels and calculated according to the QUICKI formula In addition glucose tolerance will be tested with a standard oral glucose tolerance test as well as assessment of blood lipids and blood pressure
A total of 176 males will be recruited and randomized for the study after a screening procedure to verify eligibility for the study Males who can participate must fulfil a series of inclusion and exclusion criteria which in addition to the metabolic syndrome and low testosterone levels require HbA1c levels below 75 stable blood pressure control and cholesterol levels below 8 mmolL Medical treatment for these conditions are accepted but diabetes treatment is limited to metformin
Before entering into the study and during the study males will be followed with blood tests and glucose tolerance assessment and physical examination In all the study requires five clinical visits Base-line observations and randomization visit two visits during the treatment phase after 12 and 23 weeks of therapy and a follow-up visit after cessation of therapy
A few exploratory variables will be assess such as markers for changes in cholesterol metabolism adiponectin and all subjects in the study will be characterized with genotype analysis of CAG repeat polymorphism of the androgen receptor A subset of patients will be examined with CT of the abdomen to assess eventual changes in intra abdominal fat mass and liver attenuation
Safety procedures involve assessment of the prostate digital rectal examination and PSA levels and Hb levels at baseline and throughout the study
Study medication Males enrolled in the study will be treated with daily application of 75 g of a 1 testosterone hydroalcoholic gel 75 mg of testosterone applied on specified skin sites or a placebo gel
Time plan The study is planned to start in q2 2007 at 12 different centres in Austria Germany and Sweden Each centre is anticipated to recruit 10 -30 subjects during a 2 months period To facilitate recruitment newspaper advertising and web based eligibility screening will be used if feasible After an 1-3 weeks screening period eligible subjects are randomized to active or placebo therapy Two evaluations are made during the treatment phase the first after 12 and the second after 24 weeks Efficacy and safety assessments are performed at these visits Competitive enrolment is used after the first six weeks of the recruitment period enabling all centres to recruit an up-front agreed number of subjects
Data capturing and laboratory routines A centralized internet based system will be used for data capturing communication with the study staff and automatic entry of laboratory data All laboratory analysis will be performed at or through a core laboratory LFK in Kiel A paper CRF will be used for primary entry of patient data which are subsequently transcribed into an electronic CRF All study centres will be trained during the investigators meeting in management of the data capturing system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None