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Trial registered on ANZCTR


Registration number
ACTRN12612000293864
Ethics application status
Approved
Date submitted
24/02/2012
Date registered
13/03/2012
Date last updated
28/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Study of the Effects of GC811007 Administration on Copper and Trace Metal Metabolism in Non-diabetic Subjects and Patients with Type 2 Diabetes Mellitus
Scientific title
Pilot Study of the Effects of GC811007 Administration on Copper and Trace Metal Metabolism in Non-diabetic Subjects and Patients with Type 2 Diabetes Mellitus: a randomized, double-blind, placebo-controlled trial in adult males with Type 2 diabetes mellitus and non-diabetic subjects to measure the effects on urinary copper, zinc and iron excretion.
Secondary ID [1] 280004 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 285913 0
Condition category
Condition code
Metabolic and Endocrine 286103 286103 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a randomized, double-blind, placebo-controlled trial in adult males with Type 2 diabetes mellitus and non-diabetic subjects; the two groups were age-matched. Within each group, half received GC811007 2400 mg/day taken once daily for the six day treatment period before breakfast, supplied as 300-mg capsules; and half received placebo. After the screening visit, subjects resided at the study site for a 6-day baseline period and a 6-day treatment period, during which all food and beverages were provided and measured to control intake of dietary Cu and other trace metals.
Intervention code [1] 284329 0
Treatment: Drugs
Comparator / control treatment
Placebo was supplied as microcrystalline cellulose (Vivapur type 102) in opaque Capsugel gelatin capsules
Control group
Placebo

Outcomes
Primary outcome [1] 286579 0
change in urine Cu excretion as measured from:
- 24-h urine collections throughout the baseline (diet only, Days 1-6) and treatment periods (GC811007 or placebo, Days 7-12)
Timepoint [1] 286579 0
Days 1-6 - baseline measurements;
Days 7-12 - treatment periods
Primary outcome [2] 286580 0
change in urine Cu excretion as measured from:
- 2-h urine collections during the first 10-h of the baseline (Diet only, Day 1) and treatment (GC811007 or placebo, Day 7) periods
Timepoint [2] 286580 0
Day 1 and Day 7
Primary outcome [3] 286581 0
change in Cu excretion as measured from:
24-h fecal collections throughout the baseline (Diet only, Days 2-7) and treatment periods (GC811007 or placebo, Days 8-13)
Timepoint [3] 286581 0
Baseline at Days 2-7
Days 8-13 post-treatment
Secondary outcome [1] 296210 0
Cumulative Cu excretion by both urine and fecal collections.
Timepoint [1] 296210 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)
Secondary outcome [2] 296211 0
Dietary copper intake compared with urine and fecal excretion
Timepoint [2] 296211 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)
Secondary outcome [3] 296212 0
Circulating serum Mg levels
Timepoint [3] 296212 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)
Secondary outcome [4] 296213 0
Trace metal excretion = both urine and fecal excretion
Balance = intake compared with urine and fecal excretion
Timepoint [4] 296213 0
Daily measurements for 6 days (Diet only, days 1-6 = pretreatment)
Days 7-12 Treatment periods (GC811007 or placebo)

Eligibility
Key inclusion criteria
Male patients with Type 2 diabetes, and non-diabetic healthy male subjects with normal glucose tolerance test; normal ECG; normal serum levels of iron and ferritin; willingness to participate in a residential study for 12 days
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Female Gender, abnormal GTT; abnormal ECG; Abnormal serum iron and ferritin; unable to participate in a 12 day residential study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/06/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4164 0
New Zealand
State/province [1] 4164 0

Funding & Sponsors
Funding source category [1] 284764 0
Commercial sector/Industry
Name [1] 284764 0
Protemix Corporation
Country [1] 284764 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Protemix Corporation
Address
Protemix Corporation Ltd.
PO Box 2165, Shortland Street
Auckland 1140
Country
New Zealand
Secondary sponsor category [1] 283654 0
None
Name [1] 283654 0
Address [1] 283654 0
Country [1] 283654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286775 0
Auckland Health & Disabilities Ethics Committee
Ethics committee address [1] 286775 0
Ethics committee country [1] 286775 0
New Zealand
Date submitted for ethics approval [1] 286775 0
Approval date [1] 286775 0
Ethics approval number [1] 286775 0
2001/026

Summary
Brief summary
The study was designed to explore the effects of GC811007 on trace metal metabolism in patients with T2DM and healthy non-diabetic subjects; specifically we wanted to investigate the effects of GC811007 on trace metal urine and fecal excretion under carefully controlled dietarty conditions in order to calculate trace element balance over a period of 6 days. We hypothesised firstly that baseline urine copper excretion would be raised in T2DM indicative of raised whole-body copper status which is a pro-oxidant status, and secondly that treatment with GC811007 would increase urine and fecal copper losses, and engender a negative copper balance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33820 0
Address 33820 0
Country 33820 0
Phone 33820 0
Fax 33820 0
Email 33820 0
Contact person for public queries
Name 17067 0
Dr Sally Poppitt
Address 17067 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckland 1142
Country 17067 0
New Zealand
Phone 17067 0
+64 (9) 630 5160
Fax 17067 0
Email 17067 0
[email protected]
Contact person for scientific queries
Name 7995 0
Dr Garth Cooper
Address 7995 0
School of Biological Sciences
University of Auckland
Private Bag 92 019
Auckland 1142
Country 7995 0
New Zealand
Phone 7995 0
+64 (9) 923 7239
Fax 7995 0
Email 7995 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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