Effect of Magnesium in DiabetesNCT03002545
Magnesium Supplementation in Type II Diabetes
A study testing Magnesium citrate in people with Effect of Magnesium in Diabetes, run by Protina Pharmazeutische GmbH at 1 site in Germany.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Effect of Magnesium in Diabetes
- What is being tested?
- Magnesium citrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II Diabetics (HbA1c > 6%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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 .
Read the 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).
- Conditions
- Effect of Magnesium in Diabetes
- Being tested
- Magnesium citrate, Placebo
- Keywords
- Magnesium, Type II diabetes, magnesium-sensitive genes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium citrateDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | identically tasting and looking Placebo Receives: Dietary Supplement: Placebo |
| Magnesium | Active comparator | Supplementation with 400 mg Magnesium from Magnesium citrate once daily Receives: Dietary Supplement: Magnesium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sampling
measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression
Measured: 12 weeks
blood pressure measurement
measurement of blood pressure
Measured: 12 weeks
questionnaire SF-36
questionnaire is used to assess the physiological health Status of patients
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Magnesium in DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protina Pharmazeutische GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002545
- Sponsor's protocol ID
- DiaMag 2017
- Status last verified
- Aug 2019
- First submitted
- 19 Dec 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03002545
- Acronym / sponsor ID
- DiaMag 2017
- Conditions
- Effect of Magnesium in Diabetes
- Keywords
- Magnesium, Type II diabetes, magnesium-sensitive genes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Protina Pharmazeutische GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboidentically tasting and looking Placebo |
| Magnesium | Active comparator | Dietary Supplement: Magnesium citrateSupplementation with 400 mg Magnesium from Magnesium citrate once daily |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type II Diabetics (HbA1c > 6%)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium citrate | Dietary supplement | Magnesium |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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
questionnaire SF-36
Time frame: 12 weeks
questionnaire is used to assess the physiological health Status of patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium citrate in people with Effect of Magnesium in Diabetes, run by Protina Pharmazeutische GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood sampling (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.