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
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
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
In an 8 week randomised controlled trial, patients with type 2 DM (n=30) will be randomised into one of two treatment groups to receive either exercise and 30 mg/d elemental zinc (‘Zn + exercise group’) or exercise and placebo (‘Exercise group’). Supplementation will occur over the 8 week intervention, with exercise training conducted in the last week of the study period. All participants will undergo supervised daily exercise training for 60 min/day at 60% of maximal fitness capacity for 7 consecutive days. During the study, participants will be asked to provide three fasting blood samples in total (baseline, week 6 and week 8). Blood samples will be analysed for glucose, insulin, lipids and zinc. Peripheral blood mononuclear cells (PBMC) will be isolated for the assessment of cellular zinc status which includes the expression of zinc transporter, metallothionein, and mediators of insulin sensitivity will be measured. Insulin sensitivity will be measured by hyperinsulinemic, euglycaemic clamps on three occasions (baseline, week 6 and week 8) during the intervention period. A skeletal muscle biopsy may be obtained during the clamp, with participant's additional consent.
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
[email protected]
Contact person for public queries
Name 54519 0
Ms 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&[email protected]
Contact person for scientific queries
Name 54520 0
Prof 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
[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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.