Trial summary

The purpose of this study is to understand how oestrogen controls the use of fat in the liver. The hypothesis is that oestrogen is required to prevent the accumulation of fat in the liver. The mechanism may be direct or mediated by other hormones such as growth hormone, which is regulated by oestrogen. 
We wish to study the effects of oestrogen compounds called Selective Oestrogen Receptor Modulators (tamoxifen) and a drug that prevents oestrogen production (letrozole) on the secretion of growth hormone from the special gland in brain and how they control the liver production and burning of fat in men and women. We wish to compare these effects with that of natural oestrogen itself in women.

Broad Health ConditionNeuroendocrine regulation of GH secretion by oestrogens
Metabolic effects of oestrogens

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment3/08/2010

Phase of TrialPhase 4

Has the study received ethics approval?Approved

Key inclusion criteria

Healthy postmenopausal women and men the same age
BMI <25 kg/m2

Minimum age50 Years

Maximum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

History of liver, kidney diseases, cancer, diabetes, endocrine disorders, that are likely to interfere with the metabolism or excretion of the test medication.

Trial summary

Advanced prostate cancer is the second leading cause of cancer death in Australian men. Chemotherapy (Docetaxel) is effective in only 50% of patients with this disease. A molecule, MIC-1, is a potential predictive blood marker and mediator of Docetaxel resistance. This clinical trial will test whether the MIC-1 blood test is a predictor of Docetaxel resistance.

Broad Health ConditionMetastatic castrate-resistant prostate cancer

Specific Health ConditionCancer
Prostate

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/01/2010

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1.	Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
2.	Confirmed castrate-resistant prostate cancer (CRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment.
3.	Patients must have a baseline serum PSA > 10 ng/ml (referred to as PSA #1), and two consecutive rises in serum PSA (referred to as PSA #2 and PSA #3) greater than PSA #1 with each test performed at least one week apart. If PSA #3 is less than PSA #2, the patient remains eligible provided a fourth PSA (PSA #4) is greater than PSA #2.
4.	Age > 18 years.
5.	Eastern Cooperative Oncology Group Performance status 0-3.
6.	A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre.
7.	Normal bilirubin level and aspartate aminotransferase, alanine aminotransferase and serum creatinine no more than 1.5 times the upper limit of the normal range.
8.	Castrate testosterone levels due to either gonadotrophin-releasing hormone (GNRH) agonists or orchidectomy.
9.	Informed consent.

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

1. No histological diagnosis of prostate cancer

Trial summary

Vitamin D deficiency is common amongst people with type 2 diabetes. People with type 2 diabetes frequently develop painful neuropathy ("nerve pain" especially in the feet). The study hypothesis is that vitamin D supplementation may improve symptoms of nerve pain. The study is therefore designed to investigate the impact of vitamin D supplementation on nerve pain in people with type 2 diabetes

Broad Health ConditionNeuropathic pain in type 2 diabetes

Specific Health ConditionMetabolic and Endocrine
Diabetes
Neurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/04/2010

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Approved

Key inclusion criteria

Patients with type 2 diabetes and with painful neuropathy with a serum 25-hydroxyvitamin D level of less than 50 nmol/L

Minimum age40 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients with type 1 or secondary diabetes, hypercalcaemia or renal stone

Trial summary

The study objective is to investigate the metabolic effects of beta2-agonist in humans, including whole body energy expenditure, fat oxidation, protein synthesis and turnover

Broad Health ConditionObesity

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusPrevention

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/08/2009

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Key inclusion criteria

Healthy adults

Minimum age20 Years

Maximum age40 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Any active medical conditions necessitating medication

Trial summary

This study aims to identify inherited risk in individuals with sarcoma to aid in the creation of a research resource consisting of biospecimens and associated data.
Who is it for?
You may be eligible to join this study if you have been diagnosed with sarcoma. 
Study details
Participants will be identified at key sarcoma clinics, asked to complete a questionnarie and provide biospecimens (blood and tissue). The biospecimens will be stored indefinitely in a tissue bank to be utilised by researchers investigating genetic factors contributing to cancer. Information obtained from the questionnaire will be used to ascertain the family history of cancer and other factors that may contribute to development of the disease. The ongoing nature of the project will enable continual provision of important practical information for clinicians and patients leading to more favourable outcomes.
Sarcomas contribute disproportionately to cancer burden in our community, because they affect the young, treatment is costly and prolonged and morbidity and mortality is high. Genetic factors appear important in sarcomas, although they have not been well studied for the adult population. Early detection by identifying those at risk may lead to better prognoses. This project aims to create a vital research resource to enable further study into the genetic factors contributing to the hereditary risk of developing sarcoma. 

Broad Health Conditionsarcoma
genetic mutations

Specific Health ConditionCancer
Sarcoma (also see 'Bone') - soft tissue
Human Genetics and Inherited Disorders
Other human genetics and inherited disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,VIC

Trial location outside Australia

Country
United Kingdom

State
London

Country
India

State
Mumbai

Country
France

State
Lyon

Country
United States of America

State
Utah

Country
Korea, Republic Of

State
Seoul

Country
New Zealand

State
Canterbury

Anticipated date of first participant enrolment1/07/2009

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

All those diagnosed with sarcoma are eligible for inclusion.  Controls must be age matched within 5 years of the proband, be older than or equal to 18 years of age, not have had a cancer diagnosis and not be a blood relative.

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Controls must be older than or equal to 18 years of age

Trial summary

We aim to investigate the effects of raloxifene (SERM) in hypogonadal men on the growth hormone system and metabolism.

Broad Health ConditionMetabolic effects in men with low testosterone

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment6/02/2008

Phase of TrialPhase 4

Has the study received ethics approval?Approved

Key inclusion criteria

Hypogonadism (prostate cancer patients on androgen deprivation therapy for at least 6 months)

Minimum age40 Years

Maximum age80 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

Androgen deprivation for less than 6 months, metastasis, cancer in other tissues than prostate, diabetes, kidney and liver disease, deep vein thrombosis

Trial summary

We aim to investigate and compare the effects of raloxifene and tamoxifen (two most commonly used SERMs) in healthy men and women on the growth hormone system and metabolism.

Broad Health ConditionMetabolic effects in healthy men and healthy postmenopausal women

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusEducational / counselling / training

Recruitment statusRecruiting

Anticipated date of first participant enrolment27/11/2006

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Healthy postmenopausal women and healthy men the same age

Minimum age50 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

obesity, diabetes, cancer, kidney or liver diseases, deep vein thrombosis

Trial summary

The purpose of this study is to find out if a new genetic test (GSTP1 methylation) is a better way of assessing patients’ response to chemotherapy compared to the standard methods (eg PSA blood test). In addition, this study will attempt to find new ways of predicting patient’s response to chemotherapy before they start treatment.

Broad Health ConditionPatients with Metastatic hormone-refractory prostate cancer

Specific Health ConditionCancer
Prostate

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/07/2006

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.2. Confirmed Hormone-refractory prostate cancer (HRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment.3. Patients must have a baseline serum Prostate-specific antigen (PSA)> 10 ng/ml (referred to as PSA #1), and two consecutive rises in serum PSA (referred to as PSA #2 and PSA #3) greater than PSA #1 with each test performed at least one week apart. If PSA #3 is less than PSA #2, the patient remains eligible provided a fourth PSA (PSA #4) is greater than PSA #2.4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-3.5. A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre.6. Normal bilirubin level and AST, ALT and serum creatinine no more than 1.5 times the upper limit of the normal range. 7. Castrate testosterone levels due to either luteinizing hormone-releasing hormone (LHRH) agonists or orchidectomy.8. Informed consent.

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

 1. Patients taking alternative therapies (eg Saw Palmetto, dehydroepiandrosterone (DHEA), lycopene, PC-SPES, vitamin D, selenium).2. Patients receiving chemotherapy other than Docetaxel or Mitoxantrone (eg cyclophosphamide).

Trial summary

A prospective, non-randomised, 48 week study of the effect of PI containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.

Broad Health ConditionHIV
Metabolic abnormality
Lipodystrophy
Cardiovascular disease

Specific Health ConditionInfection
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular
Other cardiovascular diseases

Trial FocusDiagnosis

Recruitment statusRecruiting

Anticipated date of first participant enrolment3/02/2004

Phase of TrialPhase 4

Has the study received ethics approval?Approved

Key inclusion criteria

Be able to provide written consent to perform in the trial.- HIV antibody positive at time of entry to the study.Specific to HAMA part A only:- Be naive to antiretroviral medication.Specific to HAMA part B only:- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.- Have had a minimum of 48 weeks interval since completion of HAMA part A.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

General:- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subjects ability to participate in the trial.-  Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.-  Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.-  Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.-  Prior use of any retinoid-containing compound within the previous six months.- Abnormal coagulation.- Previous allergic reaction or known allergy to local anaesthetic.-  Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subjects ability to participate in all activities involved in the trial.-  Any grade-three laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements.-  Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.-  PregnancySpecific to HAMA part A only:- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors).  Entry of individuals who have had previous antiretroviral therapy as part of Post Exposure Prophylaxis will be at the discretion of the study investigators.

Trial summary

A randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects

Broad Health ConditionHIV
Lipid metabolism
Glucose metabolism
Metabolic abnormality
Lipodystrophy
Cardiovascular disease

Specific Health ConditionInfection
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular
Other cardiovascular diseases

Trial FocusDiagnosis

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/11/2004

Phase of TrialPhase 4

Has the study received ethics approval?Approved

Key inclusion criteria

Be able to provide written consent to perform in the trial. - HIV antibody negative and HIV DNA negative at time of entry to the study.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subjects ability to participate in the trial.- History of type I or type II diabetes mellitus or previous treatment with antidiabetic medication. - Prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months. - Alcohol or substance abuse which in the opinion of the investigator would affect the subjects ability to participate in the trial. - Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).- Prior use of any retinoid-containing compound within the previous six months. - Abnormal coagulation. - Previous allergic reaction or known allergy to local anaesthetic. - Previous use of psychotropic medications. - Concomitant use of medications, including those metabolised by CYP3A4 enzyme system (appendix C), which, in the opinion of the investigator, would affect the subjects ability to participate in all activities involved in the trial. - Any grade-three laboratory abnormality recorded from screening bloods. - Any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements. - Gastrointestinal disorders, which may affect drug absorption. - Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.- Pregnancy - Evidence of acute or chronic active hepatitis B virus infection by serology performed at baseline. - Evidence of hepatitis C infection by serology performed at baseline.

Trial summary

The primary purpose is to determine whether growth hormone and androgens alter protein metabolism in a way that will reduce protein loss in long-term glucocorticoid users. If so they may be a potential therapy to reduce the skin thinning and muscle weakness that occurs during longterm glucocorticoid use.

Broad Health ConditionLong-term glucocorticoid users with polymyalgia rheumatica
Inflammatory arthritis

Specific Health ConditionInflammatory and Immune System
Rheumatoid arthritis

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/07/2004

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Approved

Key inclusion criteria

Receiving prednisone for > 6 months for polymyalgia rheumatica or inflammatory arthritis.

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Diabetes mellitus, cancer, liver or kidney failure.

Trial summary

Observations from previous studies suggest that the full action of GH requires the presence of male hormones like Testosterone (T). We will test the hypothesis that T enhances GH effect acting on the liver. We will compare the body protein production after delivering T exclusively to the liver (capsules) and to peripheral tissues (patch).
The first phase (11 weeks, 6 visits) aims to find the T dose which exposes the liver to normal/physiological T levels.
The second phase (16 weeks, 5 visits) will compare the effect of delivering T to the liver and to peripheral tissues.

Broad Health ConditionMen with hypogonadism
Men with hypopituitarism

Specific Health ConditionMetabolic and Endocrine
Diabetes

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/06/2005

Phase of TrialPhase 4

Has the study received ethics approval?Approved

Key inclusion criteria

Hypogonadism or hypopituitarism (baseline T < 2 nmol/L)

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

No exclusion criteria

Trial summary

Acromegaly, GH deficiency and Cushing's syndrome all alter body protein. The aim was to compare protein metabolism in these 3 conditions to normal subjects, along with how protein metabolism changes following surgical removal of hormone-secreting tumour.

Broad Health ConditionNormal subjects
GH deficiency
Acromegaly
Cushing's syndrome

Specific Health ConditionMetabolic and Endocrine
Other metabolic and endocrine disorders

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/01/1995

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Subjects with GH deficiency, acromegaly and Cushing's syndrome and normal volunteers.

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Cancer, hepatic and renal failure.

Trial summary

The aim of this study is to determine if short-term low dose glucocorticoids alters protein metabolism in a way that results in protein loss. This information will help in the development of therapies that reverse or prevent protein loss in patients requiring long-term glucocorticoids.

Broad Health ConditionHealthy volunteers

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment3/01/2005

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

Healthy subjects.

Minimum age50 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Diabetes mellitus, cancer, liver and kidney failure.

Trial summary

Prediabetes is a common condition in overweight individuals affecting approximately 35% of
American adults and 30% of Australian adults. Like diabetes, prediabetes is a serious risk
factor for cardiovascular disease, eye, kidney and liver disease, and some types of cancer.

Appropriate blood glucose control is crucial in preventing pre-diabetes complications and
onset of diabetes, yet clinical practice, backed by randomised trials, reports that many
patients treated with standard dietary guidelines or with the first-line treatment of
diabetes patients, metformin, do not improve blood glucose control sufficiently.

The overarching goal of the present project is to improve the efficacy of metformin
mono-therapy in pre-diabetes and early type 2 diabetes.

Broad Health ConditionPre Diabetes
Insulin resistance
Metformin
Gut microbiota
Type 2 Diabetes Mellitus

Specific Health ConditionPre Diabetes
Type 2 Diabetes Mellitus

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Phase of TrialNot Applicable

Key inclusion criteria

Inclusion criteria:

    -  Individuals with pre-diabetes or newly-diagnosed (in the last 6 months) with type 2
       diabetes, fulfilling the following criteria:

    -  Impaired fasting glucose (IFG, plasma glucose [PG]- 5.6 - 6.9 mmol/L, ±0.2 mmol/L)
       and/or impaired glucose tolerance (IGT, 2-h PG 7.8 - 11.0 mmol/L, ±0.2 mmol/L) with or
       without elevated HbA1c (up to 8.0 %).

    -  Willingness to provide written informed consent and willingness to participate and
       comply with the study.

  Exclusion Criteria:

    -  Females planning a pregnancy during the course of the research or 3 months after
       completion of the research project.

    -  Patients with type 1 diabetes, chronically active inflammatory disease, neoplastic
       disease in the previous 3 years, chronic gastrointestinal disorders, including
       inflammatory bowel disease or celiac.

    -  Liver enzymes ALT and/or AST>3-times normal range limit.

    -  Abnormal renal function as measured by (eGFR<45 mL/min/1.73m^2).

    -  Individuals with a history of a psychological illness or condition that may interfere
       with the individual's ability to understand the requirements of the study.

    -  Normo-glycaemia.

    -  HbA1c>8.0%

    -  Cardiovascular event in the previous 6 months.

    -  Current or recent (within 24 months) treatment with a glucose lowering medication
       (i.e. GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4
       inhibitor or insulin).

    -  Current or recent (within 3 months) treatment with metformin.

    -  Treatment with an oral steroid.

    -  Treatment with antibiotics/antifungal in the last 3 month.

    -  Treatment with immunosuppressive medications.

    -  Alcohol or substance abuse.

    -  Participants who had received an investigational new drug within the last 6 months.

    -  Participants involved in another clinical study.

    -  Participants who actively lose weight.

    -  Participants who had a bariatric surgery.

Minimum age20 Years

Maximum age70 Years

GenderAll

Can Healthy volunteers participate?No

Trial summary

This is a multicentre prospective study of the feasibility and clinical value of a diagnostic
service for identifying therapeutic targets and recommending personalised treatment for
children and adolescents with high-risk cancer.

Broad Health Conditionchildren
precision medicine
personalised medicine
high-risk cancer
refractory
recurrent
sequencing
patient derived xenograft
molecular profiling
paediatric

Specific Health ConditionChildhood Cancer
Childhood Solid Tumor
Childhood Brain Tumor
Childhood Leukemia
Refractory Cancer
Relapsed Cancer

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,VIC,WA,

Hospital
John Hunter Children's Hospital

Hospital
Sydney Children's Hospital, Randwick

Hospital
The Children's Hospital at Westmead

Hospital
Queensland Children's Hospital

Hospital
Women's and Children's Hospital

Hospital
Royal Children's Hospital

Hospital
Monash Children's Hospital

Hospital
Perth Children's Hospital

Key inclusion criteria

Inclusion criteria (all must be met)

    1. Age = 21 years

    2. Histologic diagnosis of high-risk malignancy defined as expected overall survival <
       30% OR where standard therapy would result in unacceptable and severe morbidity

    3. Appropriate tissue samples are available for analysis

    4. Life expectancy > 6 weeks

    5. Written informed consent

Maximum age21 Years

GenderAll

Can Healthy volunteers participate?No