None listed
Conditions
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.
Interventions
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
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.
Sponsors
Hospital General de Zona No 46. Instituto Mexicano del Seguro Social
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
Exclusion criteria
1. Chronic kidney failure 2. Use of diuretics 3. Chronic diarrhea 4. Alcoholism
Outcome results
None listed