Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000157572
Ethics application status
Approved
Date submitted
2/02/2015
Date registered
18/02/2015
Date last updated
12/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Zinc and Exercise for the Treatment of Insulin Resistance
Scientific title
The effect of zinc supplementation and exercise on insulin sensitivity in type 2 diabetes mellitus
Secondary ID [1] 286078 0
Nil
Universal Trial Number (UTN)
U111111638678
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 294077 0
Condition category
Condition code
Metabolic and Endocrine 294379 294379 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30 mg/d elemental zinc supplementation for 8 weeks delivered orally in capsule form. Compliance will be checked by the count of capsule return
Aerobic exercise training supervised by an exercise scientist for 60 min/day at 60% of maximal fitness capacity on treadmill for 7 consecutive days in the last week of study.
Intervention code [1] 291069 0
Treatment: Other
Intervention code [2] 291070 0
Lifestyle
Comparator / control treatment
Placebo (rice flour) for 8 weeks delivered as oral capsule. Compliance will be checked by the count of capsule return
Aerobic exercise training supervised by an exercise scientist for 60 min/day at 60% of maximal fitness capacity on treadmill for 7 consecutive days in the last week of study.
Control group
Placebo

Outcomes
Primary outcome [1] 294170 0
Insulin sensitivity by hyperinsulinemic, euglycaemic clamp
Timepoint [1] 294170 0
Week 0, Week 6, Week 8
Primary outcome [2] 294171 0
Glycaemic control (fasting serum glucose, insulin)
Timepoint [2] 294171 0
Week 0, Week 6, Week 8
Secondary outcome [1] 312666 0
Lipidemia (fasting serum total cholesterol, LDL, HDL, triglycerides)
Timepoint [1] 312666 0
Week 0, Week 6, Week 8
Secondary outcome [2] 312667 0
Gene expression of zinc transporters and metallothionein in peripheral blood mononuclear cells and skeletal muscles by real time PCR
Timepoint [2] 312667 0
Week 0, Week 6, Week 8
Secondary outcome [3] 312668 0
Expression of mediators of insulin signaling pathways in skeletal muscles by Western blot or similar
Timepoint [3] 312668 0
Week 0, Week 6, Week 8

Eligibility
Key inclusion criteria
Patients diagnosed with type 2 DM who are physically inactive (n=30)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: habitual smokers, women who are pregnant or breastfeeding, those with diagnosis of any other major illness, the use of vitamins or mineral supplements in the last 6 weeks and medical contraindication to maximal exercise testing or exercise training.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6621 0
New Zealand
State/province [1] 6621 0

Funding & Sponsors
Funding source category [1] 290663 0
University
Name [1] 290663 0
University of Otago
Country [1] 290663 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Department of Human Nutrition
PO Box 56 Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 289356 0
None
Name [1] 289356 0
Address [1] 289356 0
Country [1] 289356 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292299 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 292299 0
Ethics committee country [1] 292299 0
New Zealand
Date submitted for ethics approval [1] 292299 0
04/12/2014
Approval date [1] 292299 0
17/02/2015
Ethics approval number [1] 292299 0
14/CEN/218

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54518 0
Prof Samir Samman
Address 54518 0
Department of Human Nutrition
University of Otago
PO Box 56 Dunedin 9054
New Zealand
Country 54518 0
New Zealand
Phone 54518 0
+64 3 479 7945
Fax 54518 0
Email 54518 0
samir.samman@otago.ac.nz
Contact person for public queries
Name 54519 0
Anna Chu
Address 54519 0
Department of Human Nutrition
University of Otago
PO Box 56 Dunedin 9054
New Zealand
Country 54519 0
New Zealand
Phone 54519 0
+64 3 479 7948
Fax 54519 0
Email 54519 0
zinc&.exercise@otago.ac.nz
Contact person for scientific queries
Name 54520 0
Samir Samman
Address 54520 0
Department of Human Nutrition
University of Otago
PO Box 56 Dunedin 9054
New Zealand
Country 54520 0
New Zealand
Phone 54520 0
+64 3 479 7945
Fax 54520 0
Email 54520 0
samir.samman@otago.ac.nz

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.