Non-Insulin Dependent Diabetes MellitusPhase 1MagInGluNCT01980459
Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis
A Phase 1 study testing magnesium lactate in people with Non-Insulin Dependent Diabetes Mellitus, run by George Washington University at 1 site in Kuwait.
Trial summary
In most diabetic patients where low blood magnesium levels occur the important depletion of cellular levels is usually not measured. This study will measure both blood and oral mucosal cell magnesium levels before and after 3 months of supplementation with magnesium tablets (the recommended dietary amount of 336… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Non-Insulin Dependent Diabetes Mellitus
- What is being tested?
- magnesium lactate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteKuwait
- Study dates
- Oct 2013to Jul 2016
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have documented hypomagnesemia (serum levels ≤ 1.8 mg/dL or 0.74mmol/L);
- Be between 20-70 years of age at the time of randomization
- Have hyperglycemia due to NIDDM metabolic syndrome or obesity
- Have at least one abnormal indicator of inflammation (e.g. elevated CRP, TNF-α)
- Have no active infection
Who cannot join
- Currently have significant gastrointestinal disorders (e.g. chronic diarrhea);
- Have impaired renal function, defined as eGFR < 60 mL/min/1.73m2 or serum creatinine > 1.3 mg/dL;
- Are current being treated for hypertension (e.g. ACE inhibitors and diuretics), heart block (e.g. EKG evidence of left bundle branch block) or heart failure (e.g. treated with aldosterone antagonists);
- Are currently pregnant;
- Have chronic inflammatory disorders (e.g. psoriasis);
- Have used of Mg supplements and Mg-rich mineral water within 6 months;
Trial locations and contacts
1 site in 1 country.
About this study
In most diabetic patients where low blood magnesium levels occur the important depletion of cellular levels is usually not measured. This study will measure both blood and oral mucosal cell magnesium levels before and after 3 months of supplementation with magnesium tablets (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be correlated with blood levels of indicators of inflammation (eg C reactive protein) to see whether the cellular levels are more reliable than blood levels of magnesium for appropriate treatment of magnesium deficiency in diabetic patients.
Read the detailed description
The anti-inflammatory effects of oral magnesium (Mg) supplementation of diabetic and metabolic syndrome patients with low serum Mg levels have been studied with increased interest in recent years. However, serum magnesium levels only represent less than one percent of total body magnesium; whereas cellular deficiency of Mg is a more reliable parameter to assess repletion of this essential mineral for correlation with indices of inflammation.
The proposed research will compare the efficacy of a 3 month period of treatment with oral Mg of diabetic patients selected for elevations of CRP, TNFα and other markers of inflammation on cellular and serum levels of Mg.
We anticipate that 50 hypomagnesemic diabetic patients will be selected for 3 months of supplementation with 336 mg of Mg lactate tablets. The repletion of serum and oral epithelial cell Mg levels will be correlated with responses of CRP, TNFα, substance P, HgbAIc and oxidative/nitrosative (ROS/RNS) stress parameters before and after treatment. Individuals will be selected from the Dasman Diabetes Institute in Kuwait. With completion of these analyses, a collaborative manuscript with joint authorship will be prepared and submitted for publication.
- Conditions
- Non-Insulin Dependent Diabetes Mellitus
- Being tested
- magnesium lactate
- Keywords
- Hypomagnesemia, Cellular Mg, Inflammation, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium lactateDietary supplement
Also called MagTabSR
Patient will be given 4 tablets a day of study supplement (Magnesium Lactate) for 3 months. Magnesium cellular and serum levels will be compared prior and post intervention.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Lactate | Experimental | Patients will receive 2 tablets twice a day of Magnesium Lactate for 3 months. Receives: Dietary Supplement: magnesium lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium.
50 hypomagnesemic diabetic patients will receive magnesium tablets (~recommended dietary allowance)for 3 months and circulating inflammatory indicators will be measured. The blood and cellular levels of magnesium will be measured (before and after treatment) to assess which parameter correlates best with efficacy in lowering inflammation indicators.
Measured: One year
Secondary outcomes (1)
Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.
Antiinflammatory indicators (CRP, TNF alpha, isoprostane, Hemoglobin A1c etc) will be measured prior to and after 3 months of magnesium supplementation .
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Insulin Dependent Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Nadia Zghoul, PhD, Dept of Clinical Research, Dasman Diabetes Institute
- Responsible party
- Principal investigator, William Weglicki, George Washington University
- Investigators
- William B Weglicki, MD, Principal investigator, George Washington UniversityNadia Zghoul, PhD, Principal investigator, Dasmin Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980459
- Sponsor's protocol ID
- IRB#071317
- Acronym
- MagInGlu
- Status last verified
- Nov 2016
- First submitted
- 22 Oct 2013
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT01980459
- Acronym / sponsor ID
- MagInGlu / IRB#071317
- Conditions
- Non-Insulin Dependent Diabetes Mellitus
- Keywords
- Hypomagnesemia, Cellular Mg, Inflammation, Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Nadia Zghoul, PhD, Dept of Clinical Research, Dasman Diabetes Institute
- Study start
- Oct 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Nov 2013 (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.
In most diabetic patients where low blood magnesium levels occur the important depletion of cellular levels is usually not measured. This study will measure both blood and oral mucosal cell magnesium levels before and after 3 months of supplementation with magnesium tablets (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be correlated with blood levels of indicators of inflammation (eg C reactive protein) to see whether the cellular levels are more reliable than blood levels of magnesium for appropriate treatment of magnesium deficiency in diabetic patients.
Detailed description
The anti-inflammatory effects of oral magnesium (Mg) supplementation of diabetic and metabolic syndrome patients with low serum Mg levels have been studied with increased interest in recent years. However, serum magnesium levels only represent less than one percent of total body magnesium; whereas cellular deficiency of Mg is a more reliable parameter to assess repletion of this essential mineral for correlation with indices of inflammation.
The proposed research will compare the efficacy of a 3 month period of treatment with oral Mg of diabetic patients selected for elevations of CRP, TNFα and other markers of inflammation on cellular and serum levels of Mg.
We anticipate that 50 hypomagnesemic diabetic patients will be selected for 3 months of supplementation with 336 mg of Mg lactate tablets. The repletion of serum and oral epithelial cell Mg levels will be correlated with responses of CRP, TNFα, substance P, HgbAIc and oxidative/nitrosative (ROS/RNS) stress parameters before and after treatment. Individuals will be selected from the Dasman Diabetes Institute in Kuwait. With completion of these analyses, a collaborative manuscript with joint authorship will be prepared and submitted for publication.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnesium Lactate | Experimental | Dietary Supplement: magnesium lactatePatients will receive 2 tablets twice a day of Magnesium Lactate for 3 months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have documented hypomagnesemia (serum levels ≤ 1.8 mg/dL or 0.74mmol/L);
- Be between 20-70 years of age at the time of randomization
- Have hyperglycemia due to NIDDM metabolic syndrome or obesity
- Have at least one abnormal indicator of inflammation (e.g. elevated CRP, TNF-α)
- Have no active infection
Key exclusion criteria (6 listed)
- Currently have significant gastrointestinal disorders (e.g. chronic diarrhea);
- Have impaired renal function, defined as eGFR < 60 mL/min/1.73m2 or serum creatinine > 1.3 mg/dL;
- Are current being treated for hypertension (e.g. ACE inhibitors and diuretics), heart block (e.g. EKG evidence of left bundle branch block) or heart failure (e.g. treated with aldosterone antagonists);
- Are currently pregnant;
- Have chronic inflammatory disorders (e.g. psoriasis);
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 lactateAlso: MagTabSRPatient will be given 4 tablets a day of study supplement (Magnesium Lactate) for 3 months. Magnesium cellular and serum levels will be compared prior and post intervention. | Dietary supplement | Magnesium Lactate |
Primary outcome
The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium.
Time frame: One year
50 hypomagnesemic diabetic patients will receive magnesium tablets (~recommended dietary allowance)for 3 months and circulating inflammatory indicators will be measured. The blood and cellular levels of magnesium will be measured (before and after treatment) to assess which parameter correlates best with efficacy in lowering inflammation indicators.
1 secondary outcome
Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.
Time frame: One year
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 30 Nov 2016.
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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.
William B Weglicki, MD principal investigator
George Washington University
Nadia Zghoul, PhD principal investigator
Dasmin Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing magnesium lactate in people with Non-Insulin Dependent Diabetes Mellitus, run by George Washington University at 1 site in Kuwait.
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 5 inclusion and 6 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 30 Nov 2016. 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 Kuwait. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium. (time frame: One year). 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 30 Nov 2016.