Effects of a 12-week Supplementation With 400 mg Magnesium From Magnesium Citrate on Blood Sugar, Blood Pressure and Expression of Magnesium-sensitive Genes in Patients With Type II Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Protina Pharmazeutische GmbH
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- questionnaire SF-36
Study Overview
Brief Summary
This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium from organic magnesium citrate affects blood glucose control and insulin resistance within patients with type 2 diabetes (HbA1c> 6%) and how the expression of certain Mg-sensitive transporting genes is affected .
Detailed Description
The examinations are carried out in 50 subjects aged 20-80 years with existing type 2 diabetes (HbA1c> 6%). The target parameters are determined in the blood. Blood sampling takes place at confinement, after 6 weeks and at the end of the study (week 12). In addition, blood pressure is determined and general health condition of each subject is recorded by a standardized questionnaire (SF-36).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type II Diabetics (HbA1c > 6%)
Exclusion Criteria
- •pregnancy, lactation
- •persons with severe renal impairment (glomerular filtration rate <30 ml / min)
- •use of insulin, oral antidiabetic drugs, diuretics, antacids or proton pump inhibitors within 4 weeks prior to study start and during the study
- •intake of vitamin supplements, dietary supplements, mineral products or possibly enriched foods containing Magnesium within 4 weeks before study start and during the study
Arms & Interventions
Placebo
identically tasting and looking Placebo
Intervention: Placebo (Dietary Supplement)
Magnesium
Supplementation with 400 mg Magnesium from Magnesium citrate once daily
Intervention: Magnesium citrate (Dietary Supplement)
Outcomes
Primary Outcomes
questionnaire SF-36
Time Frame: 12 weeks
questionnaire is used to assess the physiological health Status of patients
blood sampling
Time Frame: 12 weeks
measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression
blood pressure measurement
Time Frame: 12 weeks
measurement of blood pressure
Secondary Outcomes
No secondary outcomes reported