Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000848707
Ethics application status
Approved
Date submitted
20/04/2013
Date registered
1/08/2013
Date last updated
8/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Magnesium supplementation on metabolic control in type 2 diabetic subjects
Scientific title
A randomised, placebo-controlled, double-blind, cross-over study of the effects of Magnesium supplementation on metabolic control in type 2 diabetic patients
Secondary ID [1] 282318 0
None
Universal Trial Number (UTN)
U1111-1141-8501
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 288861 0
Metabolic control 288862 0
Condition category
Condition code
Metabolic and Endocrine 289204 289204 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred diabetic patients were randomly assigned to receive two tablets Magnesium lactate 3.7 mmol (n=50) twice a day or placebo (n=50) during three months. After a washout period of three months each patient was then treated with the alternative regimen for an additional three months period. The treatment adherence will be assessed by measuring the urinary Magnesium clearance and counting the tablets taken after each intervention period. The difference will be calculated as a percentage of the number that should have been taken. Non-adherence (<80% or >120%) will be treated as protocol violation.
Intervention code [1] 286933 0
Treatment: Drugs
Comparator / control treatment
Placebo will be taken in the same frequency as the intervention treatment.
The placebo tablet will have the same outward appearance as the intervention tablet.
Control group
Placebo

Outcomes
Primary outcome [1] 289316 0
Glycemic control as evaluated by glycated hemoglobin and fast glycemia
Timepoint [1] 289316 0
At baseline and after every intervention period
Secondary outcome [1] 302230 0
Insulin resistance estimated according to the Homeostasis Model Assessment (HOMA)
Timepoint [1] 302230 0
At baseline and after every intervention period

Eligibility
Key inclusion criteria
1. Type 2 diabetics with less than 15 years diagnosed.
2. Under treatment with diet, excercise or oral hypoglycemic agents.
3.- Adequate renal function
4.- Absence of any type of cancer
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic kidney failure
2. Use of diuretics
3. Chronic diarrhea
4. Alcoholism

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)
The subjects will be recruited from those receiving attention in the diabetic clinic of Familial Medicine Unit 43 of the Mexican Social Security Institute. Subjects will be randomly assigned to receive Magnesium or placebo. Concealment by allocation schedule held independently by central administration staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was achieved by the use of a computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary endpoint was glycated haemoglobin. For detecting a difference of 10% or more between the two treatments with a power of 0.8 and a = 0.05, patients group size was calculated at 30. However 50 subjects by group will be selected to allow for non-compliance to therapy and assuming a dropout of 40%. Differences between groups will be estimated by two tailed paired Student t or Mann- Whitney test. Chi-squared test will be used for categoric variables. Differences will be considered to be statistically significant for P values lower than 0.05. Statistical analyses will be performed using SPSS IBM V 18 software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2012
Actual
1/05/2012
Date of last participant enrolment
Anticipated
1/08/2012
Actual
10/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5023 0
Mexico
State/province [1] 5023 0
Tabasco

Funding & Sponsors
Funding source category [1] 287130 0
University
Name [1] 287130 0
Universidad Juarez Autonoma de Tabasco
Country [1] 287130 0
Mexico
Primary sponsor type
Hospital
Name
Hospital General de Zona No 46. Instituto Mexicano del Seguro Social
Address
Carretera Villahermosa-Frontera SN.
Colonia Casa Blanca 86090
Villahermosa, Tabasco
Country
Mexico
Secondary sponsor category [1] 285901 0
None
Name [1] 285901 0
Address [1] 285901 0
Country [1] 285901 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289135 0
Comite Local de Investigacion en Salud 2701
Ethics committee address [1] 289135 0
Hospital General de Zona No 2
Francisco Trujillo Gurria SN
Colonia Pueblo Nuevo
Cardenas Tabasco C.P. 86500
Ethics committee country [1] 289135 0
Mexico
Date submitted for ethics approval [1] 289135 0
Approval date [1] 289135 0
18/01/2012
Ethics approval number [1] 289135 0
R-2012-2701-1

Summary
Brief summary
This is a randomized, placebo-controlled, double blind, cross-over study to investigate the effects of Magnesium supplementation on metabolic control in type 2 diabetic patients. A group of 100 patients were iniitially selected and divided to receive two tablets Magnesium lactate 3.7 mmol twice a day (n=50) or placebo (n=50) during three months. After a washout period of three months, each patient was then treated with the alternatively regimen for an additional three months period. Glycemia,glycated hemoglobin, insulin, serum Magnesium and urine Magnesium excretion and other routine biochemical parameters will be performance at the baseline and after intervention period. Comparison between groups will be carried out by the paired Student t test or Mann Whitney test.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39214 0
Dr Jorge Luis Ble Castillo
Address 39214 0
UNIVERSIDAD JUAREZ AUTONOMA DE TABASCO
PROFESSOR-RESEARCHER
AV GREGORIO MENDEZ 2838-A
COLONIA TAMULTE DE LAS BARRANCAS 86150
VILLAHERMOSA, TABASCO
Country 39214 0
Mexico
Phone 39214 0
(+52) 993 3145466
Fax 39214 0
Email 39214 0
jorge.ble@ujat.mx
Contact person for public queries
Name 39215 0
Dr Adrian Navarrete Cortes
Address 39215 0
MEDICO NO-FAMILIAR (MEDICINA INTERNA)
INSTITUTO MEXICANO DEL SEGURO SOCIAL
AV UNIVERSIDAD S/N
COLONIA CASA BLANCA
VILLAHERMOSA TABASCO 86060
Country 39215 0
Mexico
Phone 39215 0
(+52) 993 3517929
Fax 39215 0
Email 39215 0
adrianavarrete@msn.com
Contact person for scientific queries
Name 39216 0
Dr Jorge Luis Ble Castillo
Address 39216 0
UNIVERSIDAD JUAREZ AUTONOMA DE TABASCO
PROFESSOR-RESEARCHER
AV GREGORIO MENDEZ 2838-A
COLONIA TAMULTE DE LAS BARRANCAS 86150
VILLAHERMOSA, TABASCO
Country 39216 0
Mexico
Phone 39216 0
(+52) 993 3145466
Fax 39216 0
Email 39216 0
jorge.ble@ujat.mx

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

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