None listed
Conditions
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.
Interventions
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
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.
Sponsors
Protemix Corporation
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
Yes
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
Exclusion criteria
Female Gender, abnormal GTT; abnormal ECG; Abnormal serum iron and ferritin; unable to participate in a 12 day residential study.
Outcome results
None listed