Search results from the Australian New Zealand Clinical Trials Registry

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Metabolic effects of oestrogen compounds in men with low testosterone

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Trial Information

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?Further information iconApproved

Eligibility

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
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincent's Hospital
Primary Sponsor Address: 390 Victoria St Darlinghurst, NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12608000537358

Contact person for information and recruitment
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria Street Darlinghurst 2010 NSW
02 9295 8482
02 9295 8481
Further information iconk.ho@garvan.org.au
Australia

Metabolic Effects of SERMs (Selective Oestrogen Receptor Modulators) in healthy men and healthy postmenopausal women

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Trial Information

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


Postcode
2010

Anticipated date of first participant enrolment27/11/2006

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

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
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincent's Hospital
Primary Sponsor Address: 390 Victoria St Darlinghurst, NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12607000586415

Contact person for information and recruitment
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria Street Darlinghurst 2010 NSW
02 9295 8482
02 9295 8481
Further information iconk.ho@garvan.org.au
Australia

Prospective Study to investigate the ability of the Glutathione S- transferase Pi (GSTP1) methylation assay to assess response to chemotherapy in patients with metastatic hormone-refractory prostate cancer

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Trial Information

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

Has the study received ethics approval?Further information iconApproved

Eligibility

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).
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Lisa Horvath
Primary Sponsor Address: Sydney Cancer Centre Royal Prince Alfred Hospital Missended Rd CAMPERDOWN NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12607000077460

Contact person for information and recruitment
Mr Quoc Nguyen
PRIMe The Garvan Institute of Medical Research 384 Victoria St DARLINGHURST NSW 2010
+61 2 92958349
+61 2 9295 84223
Further information iconq.nguyen@garvan.org.au
Australia

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA 001)

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Trial Information

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?Further information iconApproved

Eligibility

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.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Country: Australia

Trial IDACTRN12605000662662

Contact person for information and recruitment
Patrick WG Mallon
The National Centre in HIV Epidemiology and Clinical Research Level 2 376 Victoria Street Darlinghurst NSW 2010
+61 2 83823107

Further information iconpmallon@nchecr.unsw.edu.au
Australia

Seronegatives And Metabolic Abnormalities Protocol 2 (SAMA 002)

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Trial Information

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?Further information iconApproved

Eligibility

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.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Country: Australia

Trial IDACTRN12605000661673

Contact person for information and recruitment
Patrick WG Mallon
The National Centre in HIV Epidemiology and Clinical Research Level 2 376 Victoria Street Darlinghurst NSW 2010
+61 2 83823107

Further information iconpmallon@nchecr.unsw.edu.au
Australia

Treatment of glucocorticoid-induced protein wasting

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Trial Information

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?Further information iconApproved

Eligibility

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.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia

Trial IDACTRN12605000642684

Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria St Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481
Further information iconk.ho@garvan.org.au
Australia

How androgens exert their anabolic effects. Interaction of testosterone and growth hormone at the hepatic level.

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Trial Information

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?Further information iconApproved

Eligibility

Key inclusion criteria

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

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

No exclusion criteria
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincents Hospital Sydney
Primary Sponsor Country: Australia

Trial IDACTRN12605000482662

Contact person for information and recruitment
Dr Ken Ho
Professor of Medicine Head Pituitary Research Unit Garvan Institute Chairman Department of Endocrinology Garvan Institute of Medical Research St Vincent's Hospital 384 Victoria Street Darlinghurst NSW 2010
+61 2 92958203
+61 2 92958411
Further information iconk.ho@garvan.unsw.edu.au
Australia

Protein turnover and energy expenditure in normal subjects, growth hormone deficiency, acromegaly and Cushing's syndrome

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Trial Information

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

Has the study received ethics approval?Further information iconApproved

Eligibility

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.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia

Trial IDACTRN12605000445673

Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria St Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481
Further information iconk.ho@garvan.org.au
Australia

Impact of short-term low dose glucocorticoids on protein metabolism

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Trial Information

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?Further information iconApproved

Eligibility

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.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia

Trial IDACTRN12605000443695

Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria St Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481
Further information iconk.ho@garvan.org.au
Australia

Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

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Trial Information

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

Eligibility

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:

       o 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 (6.1 - 8.0 %).

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

  Exclusion Criteria:

    -  Both male and female 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 disease (ALT and/or AST>3-times normal range limit).

    -  Renal disease (eGFR<45 mL/min/1.73m2).

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

    -  Normo-glycaemia.

    -  Cardiovascular event in the previous 6 months.

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

    -  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

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research

Trial websitehttps://clinicaltrials.gov/show/NCT03558867

Trial IDNCT03558867








PRecISion Medicine for Children With Cancer

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Trial Information

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
Lady Cilento 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

Eligibility

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

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Sydney Children's Hospitals Network

Trial websitehttps://clinicaltrials.gov/show/NCT03336931

Trial IDNCT03336931








Optimising Health in Type 1 Diabetes

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Trial Information

Trial summary

Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the
beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency,
whereby blood glucose levels rise and diabetes develops. When there is severe insulin
deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin
replacement therapy; dietary intervention is a also cornerstone of glucose management.

The Optimise Diet is a multi-pronged diet based on "best health" principles: to minimise
blood glucose rises after eating, reduce the immune cells involved in destruction of the
insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In
this study, its effects will be compared to the Standard Diabetes Diet that is currently
recommended in Australia and internationally.

Broad Health Conditionglucose
inflammation

Specific Health ConditionDiabetes Mellitus

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Phase of TrialNot Applicable

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  type 1 diabetes

  Exclusion Criteria:

    -  Women lactating, pregnant or of childbearing potential who are not willing to avoid
       becoming pregnant during the study.

Minimum age18 Years

Maximum age70 Years

GenderAll

Can Healthy volunteers participate?Accepts Healthy Volunteers

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research

Trial websitehttps://clinicaltrials.gov/show/NCT02903615

Trial IDNCT02903615